Elongated conductors and methods of making and using the same

ABSTRACT

Elongated conductors are provided. Aspects of the elongated conductors include: an elongated structure having a proximal region and a distal region, where the elongated conductor includes two or more insulated conducting members that are in fixed relative position along at least a portion of the elongated structure and extend from the proximal region to the distal region. A pattern of insulation openings among the insulated conducting members is present at one or both of the proximal and distal regions. Aspects of the invention further include methods of making the elongated conductors, as well as devices that include the elongated conductors.

CROSS-REFERENCE TO RELATED APPLICATIONS

Pursuant to 35 U.S.C. § 119 (e), this application claims priority to thefiling date of the U.S. Provisional Patent Application Ser. No.62/169,347, filed Jun. 1, 2015, the disclosure of which is incorporatedherein by reference.

INTRODUCTION

Elongated conductors, such as elongated electrical conductors, find usein a variety of different devices used in many aspects of everyday life.For example, elongated electrical conductors find use a variety ofmedical devices, including interventional, minimally invasive, surgicaland implantable devices. Medical devices currently in use include“smart” sensing and therapeutic guidewires, which may include a sensor(pressure, thermocouple, etc.) and therapeutic technology located at thetip of a guidewire. In such devices, 2 or 3 wires are generallynecessary to interface with the sensor. The sensor is most often asimple bridge based sensor, or a variable resistance based sensor, etc.

Another type of medical device that includes an elongated conductor is ageneral electrophysiology catheter. General electrophysiology cathetersoften include a plurality of macro electrodes, usually in the form ofring electrodes, concentrically placed along a catheter tip. Macroscopicwires for each electrode are threaded through the catheter body back toan extracorporeal connector, and then to a connection box, and othersignal conditioning electronics.

Elongated electrical conductors employed in today's medical devices, aswell as other types of devices, generally have a very low wire count anda large external connector. During production of such devices, thedistal and proximal connections are performed by hand or by machine,wire by wire. Wire sorting (to make the correct connections at eachend), is achieved by color-coding and visual inspection, or by inlineimpedance measurement (which is still a wire by wire check and connectprotocol). Also, after identification, the wires are generallywire-bonded to an electrode, chip, etc. of an effector at one end andthen individually soldered into a connector at the other end. Thismanufacturing protocol is time consuming and expensive.

SUMMARY

Elongated conductors are provided. Aspects of the elongated conductorsinclude: an elongated structure having a proximal region and a distalregion, where the elongated conductor includes two or more insulatedconducting members that are in fixed relative position along at least aportion of the elongated structure and extend from the proximal regionto the distal region. A pattern of insulation openings among theinsulated conducting members is present at one or both of the proximaland distal regions. Aspects of the invention further include methods ofmaking the elongated conductors, as well as devices that include theelongated conductors.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A provides a view of a proximal end of an elongated conductorhaving an axially aligned pattern of insulation openings, in accordancewith an embodiment of the invention.

FIG. 1B provides a view of a cross section of the proximal end of theelongated conductor of FIG. 1A, in accordance with an embodiment of theinvention.

FIGS. 1C-1E provide views of distal ends of elongated conductorassemblies having a transversely aligned pattern of insulation openings,in accordance with embodiments of the invention.

FIGS. 2A-2C provide views of different elongated conductors havingdifferent split transversely aligned patterns of insulation openings, inaccordance with embodiments of the invention.

FIG. 3A provides a view of a distal end of an elongated conductor havinga transversely aligned pattern of insulation openings and a woundconducting member lumen defining configuration, in accordance with anembodiment of the invention.

FIG. 3B provides a view of the proximal end of the elongated conductorof FIG. 3A, showing an axially aligned pattern of insulation openings,in accordance with an embodiment of the invention.

FIG. 3C provides a view of a cross section of the proximal end of theelongated conductor of FIG. 3B, in accordance with an embodiment of theinvention.

FIG. 3D provides an alternative view of the distal end of the elongatedconductor of FIG. 3A, in accordance with an embodiment of the invention.

FIGS. 4A and 4B provide views of an elongate conductor and a finalcatheter body constructed from the elongate conductor, in accordancewith an embodiment of the invention.

FIGS. 5A-5C provide schematics of elongate conductors demonstrating arange of end interconnection options, in accordance with embodiments ofthe invention.

FIGS. 6A-6D provide illustrations of elongate conductors with highpacking density and specialized conductor arrangements, in accordancewith embodiments of the invention.

FIGS. 7A-7C provide an illustration of a fixing step of a method offabricating at least a portion of an elongate conductor with acontrolled inter-element pitch, in accordance with an embodiment of theinvention.

FIG. 8A provides a schematic of portions of a method of fabricating anelongated conductor, in accordance with an embodiment of the invention.

FIGS. 9A-9B provide illustrations of steps of a method for fabricatingan elongated conductor, in accordance with an embodiment of theinvention.

FIGS. 10A and 10B provide illustrations of cross sections of an elongateconductor before and after a fixing step of a method for fabricating anelongated conductor, in accordance with an embodiment of the invention.

DETAILED DESCRIPTION

Elongated conductors are provided. Aspects of the elongated conductorsinclude: an elongated structure having a proximal region and a distalregion, where the elongated conductor includes two or more insulatedconducting members that are in fixed relative position along at least aportion of the elongated structure and extend from the proximal regionto the distal region. A pattern of insulation openings among theinsulated conducting members is present at one or both of the proximaland distal regions. Aspects of the invention further include methods ofmaking the elongated conductors, as well as devices that include theelongated conductors.

Before the present invention is described in greater detail, it is to beunderstood that this invention is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present invention will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges and are also encompassed within the invention, subject toany specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the invention.

Certain ranges are presented herein with numerical values being precededby the term “about.” The term “about” is used herein to provide literalsupport for the exact number that it precedes, as well as a number thatis near to or approximately the number that the term precedes. Indetermining whether a number is near to or approximately a specificallyrecited number, the near or approximating un-recited number may be anumber which, in the context in which it is presented, provides thesubstantial equivalent of the specifically recited number.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present invention, representativeillustrative methods and materials are now described.

All publications and patents cited in this specification are hereinincorporated by reference as if each individual publication or patentwere specifically and individually indicated to be incorporated byreference and are incorporated herein by reference to disclose anddescribe the methods and/or materials in connection with which thepublications are cited. The citation of any publication is for itsdisclosure prior to the filing date and should not be construed as anadmission that the present invention is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dateswhich may need to be independently confirmed.

It is noted that, as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. It is further noted that the claimsmay be drafted to exclude any optional element. As such, this statementis intended to serve as antecedent basis for use of such exclusiveterminology as “solely,” “only” and the like in connection with therecitation of claim elements, or use of a “negative” limitation.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinvention. Any recited method can be carried out in the order of eventsrecited or in any other order which is logically possible.

In further describing various aspects of the invention, elongatedconductors will be described first in greater detail, followed by areview of embodiments of methods of producing the conductors, as well asa review of various devices that may include the conductors.

Elongated Conductors

As summarized above, aspects of the invention include elongatedconductors. The phrase “elongated conductor” as used herein refers to anelongated structure having a proximal region and a distal region, whichstructure is configured to convey some entity, e.g., electrical current,charge, light, heat, a fluid, a gel, a biological sample, etc., from theproximal region to the distal region or vice versa. As the elongatedconductor is elongated, the elongated conductor has an elongatedstructure in which the length (extending from the proximal end of theproximal region to the distal end of the distal region) is longer thanthe longest cross-sectional dimension of the structure. While the ratioof length to longest cross-sectional dimension may vary, in someinstances this ratio ranges from 20:1 to 50,000:1, such as 750:1 to7,500:1, and including 1,000:1 to 5,000:1. In some instances, theelongated structure has a length ranging from 5 to 3,000 mm, such as 50to 2,000 mm and including 750 to 1750 mm, and a longest cross-sectionaldimension (e.g., diameter in those embodiments where the conductor iscylindrical in shape) ranging from 0.025 to 20.0 mm, such as 0.10 to 5.0mm and including 0.10 to 1.0 mm. The cross-sectional shape of theconductor may vary, where examples of cross-sectional shapes that may befound in the conductors include, but are not limited to: rectilinearshapes, e.g., rectangular, square, triangular, trapezoidal, etc.,curvilinear shapes, e.g., circular, oval, etc.; as well as irregularshapes. In some instances, the structure of the elongated conductor hasa circular cross section, such that the structure is cylindrical.

In the broadest sense, the elongated conductors may be configured toconvey different entities, e.g., electrical current, charge, light,heat, a fluid, a gel, a biological sample, etc. In some instances, theconductors are configured to convey electric current, such that they areelectrical conductors. In some instances, the conductors are meant toconvey light, such that they are optical fibers. In some instances, theelongated conductors may include a lumen, such that is meant to convey afluid, a gel, a biological sample, etc.

Elongated conductors of the invention include two or more insulatedconducting members that are in fixed relative position along at least aportion of the elongated structure and extend from the proximal regionto the distal region of the elongated structure. As the conductingmembers are insulated and extend from a proximal region to a distalregion of the elongated structure, they include an elongated componentof a conductive material, e.g., an electrically conductive material,which is surrounded on all sides, e.g., coated, with an insulatingmaterial. The dimensions of the conductive material elongated componentmay vary, where in some instances the elongated component has a lengthranging from 5 to 4,000 mm, such as 50 to 2,000 mm and a diameterranging from 0.004 to 1.0 mm, such as 0.01 to 0.1 mm. The thickness ofthe insulating material, i.e., coating, may also vary, ranging in someinstances from 0.0001 to 0.1 mm, such as 0.003 to 0.040 mm. Each of theinsulated conducting members of the structure may have the samedimensions, or two or more the insulating conductive members may havedifferent dimensions, e.g., differ from each other in terms of diametersuch that at least two of the two or more insulated conductors compriseconductors of differing diameter, as desired.

The number of individual conducting members, e.g., electricallyconducting wires, in the elongated structure may vary. In someinstances, the number of conducting members ranges from 2 to 100,000,such as 2 to 500, e.g., 5 to 250, including 5 to 100, e.g., 5 to 75, 5to 50 and 5 to 25. In some instances, the elongated conductors arecharacterized by having a high conducting member packing density. Whilethe conducting member packing density may vary, in some instances thepacking density ranges from 30% to 98%, such as 55% to 85% and including60% to 78%. Embodiments of the elongated conductors are characterized byhaving high gauge conducting members with tight center-to-centerconducting member pitch. In some instances, the gauge of the conductormay be 40 AWG or greater, such as 45 AWG or greater, including 50 AWG orgreater, with a center to center conducting member pitch (i.e., aninsulated conducting member pitch) ranging from 6 to 250 μm, such as 12to 75 μm and including 15 to 30 μm.

The elongated conductors may include a plurality of conducting memberswith similar or different diameter. In some instances, an elongatedconductor may include one or more conducting members with a firstcharacteristic diameter (i.e. a characteristic maximal length in atransverse direction), and one or more conducting members with a seconddiameter. The ratio of the diameters between the first and the secondconducting members may range from 1.1:1 to 20:1, such as 1.5:1 to 5:1and including 1.5:1 to 2.5:1. The diameters of the conducting membersmay be sized based on the current carrying requirements of one or morecomponents coupled thereto or a function provided thereto (e.g. such asfor providing a power current, a signal, a low rate changing current, ahigh rate changing current, a waveguide function, etc.). In someinstances, one or more of the second conducting members may be arrangedand nested in and around one or more of the first conducting members.Such an arrangement may be advantageous to optimize or match the powerrequirements to the packing density of the overall elongated conductor.

The elongated conductors may include one or more sub-groupings ofconducting members, each sub-grouping of conducting members arrangedsuch that the spatial relationship between conducting members within thesub-group are relatively fixed with respect to each other. In someinstances, one or more of the sub-group members may be pre-fixed so asto form a local shield around one or more members of the sub-group. Insome instances, one or more pairs of sub-group members may be pre-fixed(e.g., linearly fixed together, wound together, etc.), so as to form awaveguide, a twisted pair, etc. Such an arrangement may be advantageousto control current flow and limit cross-talk between conducting membersof the elongated conductor during use.

In some instances, two or more of the conducting members within anelongated conductor may be permanently bonded together at one or morelengths along the elongated conductor. Such permanent bonding may beadvantageous to limit tribological noise associated with movement andflexure of the elongated conductor during use (e.g., such as duringmovement within lumen in a body, etc.).

In some instances, one or more of the conducting members may include aplurality of additional material layers, such as a first layer and asecond layer. In instances, the first layer may be an insulatingmaterial, so as to substantially limit current flow, heat flow, lightpassage there through, as compared with passage along the length of theconducting material. In instances, the second layer may be a conductinglayer, an insulating layer, a bonding layer, etc. In some instances, oneor more conducting members in an elongated conductor may be boundtogether via the second layers of the conducting members. Thus, one ormore portions of the elongated conductor may be a substantiallymonolithic body in terms of movement, etc. (i.e., in one or more regionsof the elongated conductor, the conducting members may mechanicallybehave as a composite structure, frictional movement between conductingmembers being substantially minimal during flexure thereof). Such aninstance may be advantageous for improving handle-ability of theelongated conductor during assembly, minimizing noise between conductingmembers during use, improve impedance tolerance between adjacentconducting members in the elongated conductor, etc.

In some instances, the second layer may be constructed, at least in partfrom a conducting material. The conducting material may substantiallyprovide a return path for current through the conducting member, maycomplete a capacitive function of the conducting member (i.e., thecapacitor formed from the inner conducting material, the firstinsulating layer, and the conducting layer), etc. In aspects, aplurality of such conducting members may be bonded together with theconducting layers, so as to provide an electrical shield for theelongated conductor, etc.

In some instances, the elongated conductor may include one or moreadditional structural members, the structural member providingmechanical rigidity, increased tensile strength, or the like for theoverall elongated conductor. The structural member(s) may be arrangedamid the conducting members, they may have a diameter that is similar toor different from the conducting members, or the like. In someinstances, the structural members may be formed from ultra-high tensilestrength fibers, the structural members arranged amid the conductingmembers to improve the overall strength of the elongated conductor. Thedimensions of the structural members may be selected so as to provideenhanced packing density of the overall elongated conductor. In someinstances, one or more conducting elements may include a bindingmaterial layer, the binding material layer providing a matrix for thestructural members (i.e., a substantially continuous medium bridging theconducting members and/or the structural members). In some instances,the structural member(s) may be pre-treated (e.g., such as with asilane, siloxane, titanate, etc.) so as to bind to the binding materiallayer.

In some instances, an elongated conductor may include one or morewrapping sub-groups of conducting members and/or structural members, thewrapping sub-group configured so as to substantially surround one ormore additional conducting members within the elongated conductor. Sucha wrapping sub-group may be advantageous to form a shielding function, areturn path, etc. along the length of the elongated conductor.

In some instances, an elongated conductor may include one or moreregions along the length thereof, wherein a sub-group of conductingmembers provided therein, may be physically separated from each other.Such a configuration may be advantageous to separate sub-groups forattachment to separate connectors at the ends of or along anintermediate length of the elongated conductor.

As indicated above, the two or more insulated conducting members of theelongated conductor are in fixed relative position along at least aportion of the elongated structure. By “fixed relative position” ismeant that the conducting members are stably associated with each other,such that they do not move relative to each other, along at leastportion of the elongated structure. As the two or more conductingmembers are stably associated along at least a portion, they do not moverelative to each other in that portion under operating conditions forwhich the elongated conductors are configured to be used. In otherwords, the two or more insulated conducting members behave as acomposite structure along at least a portion of the elongated structure.The two or more conducting members may be fixed relative to each otheralong substantially the entire elongated structure. Alternatively, theremay be one or more regions along the length of the elongated structurewhere the two or more conducting members are not fixed relative to eachother, e.g., to provide strain relief, along a sub-assembly, along asplit region of the elongate conductor, etc. When present, the length ofsuch region(s) (i.e., regions that are not stably associated with eachother) may vary, ranging in some instances from 0.25 to 100 mm, such as0.25 to 10 mm. The number of such regions may also vary, where in someinstances the number ranges from 1 to 50, such as 1 to 10, e.g., 1 to 2.

Aspects of the elongated conductors include a pattern of insulationopenings among the insulated conducting members at one or both of theproximal and distal regions, or even along intermediate regions alongthe length of the elongated conductor. By “pattern of insulationopenings” is meant a collection of areas or windows (i.e., voids) amongthe insulation of the conductive members in the region of interest,e.g., proximal or distal region. The proximal and distal regions arelocated, respectively, in the vicinity of the proximal and distal endsof the conductive structure, where a given proximal and distal regionwill be positioned from 0 to 1,000 mm, such as 0 to 50 mm (e.g., 0 to 25mm, 0 to 10 mm, including 0 to 5 mm) from its corresponding end of thestructure. The area and shape of each insulation opening of the patternmay vary, where in some instances the area ranges from 10 μm² to 10 mm²,such as 250 μm² to 2 mm². While the shape of the individual openings mayvary, examples of suitable shapes include, but are not limited to:rectilinear shapes, e.g., rectangular, square, triangular, trapezoidal,etc., curvilinear shapes, e.g., circular, cylindrical, oval, etc.; aswell as irregular shapes. As the pattern of insulation openings is amongthe insulated conducting members, a given pattern is made up of openingspresent in different conductive members. For example, a given pattern ofopenings may be made of an opening found in each of the differentconductive members present in the conductor region of interest, e.g.,proximal or distal region. In some instances, a given pattern ofopenings is made up of a single opening found in each of the differentconductive members present in the conductor region of interest, e.g.,proximal or distal region. In some instances, a given pattern ofopenings may include a plurality of openings associated with a givenconductive member (e.g., such as a conductive member configured forproviding power, to reduce interconnection impedance, etc.), or evenexclude a conductive member (e.g., such as for a split configuration,multiple interconnects along the length of the elongated conductor,etc.).

The elongated conductor may include a pattern of insulation openings,e.g., as described above, at just one of the proximal and distalregions. Alternatively, a pattern of insulation openings may be presentat each of the proximal and distal regions, such that the elongatedstructure comprises a first pattern of insulation openings among theinsulated conducting members at the proximal region and a second patternof insulation openings among the insulated conducting members at thedistal region. In some instances, the patterns may be encoded to eachother, such that, without handling or separately identifying anindividual conducting member, a predetermined encoding of the windows ofone pattern may be linked to a predetermined encoding of windows on acorresponding pattern (i.e., windows associated with a particularconducing member may be position ally known a priori based on thepredetermined encoding). Such a configuration may be advantageous foreasy handling of and interconnection with one or more device components(e.g., a flex circuit, a connector, an integrated circuit, a die, asensor, one or more electrodes, etc.), with the elongated conductor.

Within a given pattern of insulation openings, the arrangement of theindividual openings of the pattern may vary greatly, as desired. Suchpatterns may take on seemingly random or characteristic configurations.

In some instances, the pattern is an axially aligned pattern ofinsulation openings. By “an axially aligned pattern of insulationopenings,” is meant that the pattern of openings is positionedsubstantially along the long axis of the elongated conductor in theregion of interest (e.g., a window associated with a particularconducting member may be known by the location of the window withrespect to an end of the elongated conductor). FIG. 1A provides anillustration of an axially aligned pattern of insulation openings. Asshown in FIG. 1A, a completed connector tip 120 a of an elongated body100 (e.g., a guide wire, a catheter, a lead assembly, etc.), theconnector tip 120 b exposing the underlying insulating wires 111 andconnector contacts 107, and a connector tip 120 c exposing theinsulating wires 111 and insulated openings 113. As shown in FIG. 1A,proximal end 120 a,b,c of elongated conductor 100 includes insulatedwires (111) that extend in a packed configuration in a substantiallycylindrical assembly of wires. An insulation opening 113 is presentalong the length of each of the insulated wires 111. As the windows 113positioned along each of the wires 111 is staggered, the openings areaxially arranged along the length of the assembled wires in an axiallyaligned pattern of insulation openings. As shown in FIG. 1A, the axiallyaligned pattern of insulation openings 113 is made up of an insulationopening in each of the different wires 111 making up the wire assemblyof the of the elongated conductor 100 at the proximal end. In someinstances, the wire assembly is surrounded by a sheath 115, e.g., inaccordance with embodiments of the present invention. The remainingportion of the elongated conductor 100 is not specifically shown, butthe proximal end 120 a,b,c is coupled 117 to other regions in of theelongated conductor, in accordance with embodiments of the presentinvention.

FIG. 1B, provides an illustration of a cross section of the elongatedbody 100 shown in FIG. 1A as cut along a transverse plane through theelongated body 100 through one of the connector contacts 107. Theinsulating wires 111 are shown in an assembled arrangement. Theinsulating wire 111 a encoded for the connector contact 107 a, is shownwith a window 113 formed through the cross section of FIG. 1B.

In some instances, the pattern is a substantially transversely alignedpattern of insulation openings. By “a transversely aligned pattern ofinsulation openings,” is meant that the pattern of openings assumes asubstantially linear arrangement across a plurality of two or moreconducting members in the conductor region of interest, wherein thelinear arrangement is substantially orthogonal, if not orthogonal, tothe long axis of the structure made up of the conducting memberassembly.

FIG. 1C provides an illustration of a transversely aligned pattern ofinsulation openings. As shown in FIG. 10, distal end 110 of elongatedconductor 100 includes insulated wires (111) assuming a flatconfiguration on the surface of a planar support 122. An insulationopening 112 is present in each of the insulated wires 111. The openingsare transversely arranged across the assembled wires in a lineararrangement that is orthogonal to the long axis 121 of elongatedconductor 100. As shown in FIG. 10, the transversely aligned pattern ofinsulation openings 112 is made up of an insulation opening in each ofthe twelve different wires 111 making up the wire assembly of the of theelongated conductor 100. In some instances, a particular conductingmember may be provided with 3 or more insulation openings (e.g., such asto provide charge, current, light, etc. to a plurality of sites alongthe elongated conductor). As shown in FIG. 10, the insulation openings112 are shown in a purely orthogonal arrangement with respect to thelong axis 121 of the elongated conductor 100. In some instances, analternative pattern may be warranted (e.g., so as to form a low profileinterconnect with a flexible circuit, an integrated circuit, etc.).

FIG. 1D provides an illustration of a substantially transversely alignedpattern of insulation openings 133 with a staggered pattern 132. It isnoted that the staggering of the patterned 132 insulation removal is notrequired, but can be done to improve the pitch between wires withoutrisking bridging between the contacts during reflow, thermo-compressivefixation, or other type of post formed attachment or assembly process.

FIG. 1E provides an illustration of a transverse aligned pattern ofinsulation openings as inserted 157 into a sheath 155. In instances, thepatterned region of the elongated conductor 151 may be potted within thesheath 155. In instances, the patterned region may be attached to acomponent, a flexible circuit, an integrated circuit, a connector, etc.

In some instances the elongated structure may include a splitconfiguration and/or a length including a plurality of patternedregions. A split configuration means, a configuration where at least aportion of the conducting members within an elongated structure areseparated from the others over a length, such that two or more separatedgroups of conducting members are present along a cross section over thelength. The separated groups may be interfaced with separate connectors,may be interfaced with separate circuits, may be interfaced with thesame circuit, may be configured so as to reduce an overall width of theelongate structure over the length, etc.

FIGS. 2A-2C provide views of different elongated conductors havingdifferent split transversely aligned patterns of insulation openings, inaccordance with embodiments of the invention. FIG. 2A provides anillustration of a split-elongated conductor 200 with a splitconfiguration. The split configuration includes a region with twosub-groups 201, 203 of conducting members that are individuallypatterned for separate attachment to a component 205. In this instance,the component 205 is a flexible circuit, the sub-groups 201, 203patterned 207, 209 so as to interface with matching patterns on thecomponent 205. The sub-groups 201, 203 are shown supported bycorresponding supporting members 207, 209. Such a configuration may beadvantageous to provide a highly compact and easily handled approach tocoupling an elongated conductor to a component 205. The splitconfiguration may be advantageous to reduce the overall maximumtransverse dimension of the elongated conductor in the vicinity of thesub-groups 201, 203. In the embodiment shown in FIG. 2A, the splitconfiguration is configured to provide operable coupling to opposingsides of a component, such as component 205.

FIG. 2B provides an illustration of a split-elongated conductor 220 witha split configuration. The split configuration includes a region withtwo sub-groups 221, 223 of conducting members that are individuallypatterned for separate attachment to a component 225. In this instance,the component 225 is an interposer patterned with conducting traces soas to interconnect one or more integrated circuits 227 to the sub-groups221, 223. The sub-groups 221, 223 are patterned 229, 231 so as tointerface with matching patterns on a surface of the component 225. Thesub-groups 221, 223 are shown supported by corresponding supportingmembers 233, 235. Such a configuration may be advantageous to reduce themaximum transverse dimension of the elongated conductor in the vicinityof the component 225. In some instances, the component 225 may includeone or more sensors, processors, memory elements, analog to digitalcircuits, filters, serialization circuits, amplifiers, or the like. Inthe embodiment shown in FIG. 2B, the split configuration is configuredto provide operable coupling to the same side of a component, such ascomponent 225. FIG. 2C provides an illustration of an elongatedconductor including a plurality of patterned regions 243, 247, along thelength of a sub-group of conducting members 240 therein. A firstpatterned region 243 is shown coupled with a component 245. In thisinstance, the component 245 is a passive circuit element (e.g., a bypasscapacitor, an inductor, etc.). A second patterned region 247 is showncoupled with a component 249. In this instance, the component 249 is asystem in package including a substrate and one or more integratedcircuits 251. The patterned regions 245, 247 are separated by adistance, e.g., ranging from 0.01 to 25 mm, such as 1 to 15 mm, suchthat the flexibility of the overall elongated conductor is notsubstantially affected by the presence and interconnection with thecomponents 245, 249.

In some instances, the patterned regions may be configured to interfacewith one or more interposers, inline bypassing circuits or elements,flip chips, silicon dies, sensors, electrodes, etc. The positioning ofthe patterned regions may be established such that the flexibility ofthe overall elongated conductor may be maintained during use. Thus thecomponents may be distributed along daisy chains of the patternedregions for maintaining flexibility, etc.

In those instances where the elongated structure includes a pattern ofinsulation openings at both the distal and proximal regions, the patternmay be the same type of pattern in each of the proximal and distalregions, or the pattern may be a different type of pattern in each ofthe proximal and distal regions. For example, the elongated conductormay include both a transversely aligned pattern of insulation openingsand an axially aligned pattern of insulation openings, where thetransversely aligned pattern is present in one of the distal andproximal regions and the axially aligned pattern is present in the otherof the distal and proximal regions.

The arrangement of the different conducting members in the elongatedconductor may vary, as desired. For example, the different insulatedconducting members may assume a wound configuration along at least aportion of the elongated structure. By “wound configuration” is meantthat the conducting members are wound about a long axis of the elongatedstructure, such as the central long axis of the elongated structure. Insome instances, each conducting member of the wound configurationassumes a helical configuration. In such instances, the pitch of thehelical configuration may vary, ranging in some instances from 0.1 to1,000 mm, such as 0.25 to 5 mm. In these embodiments, the conductingmembers assume a wound configuration along at least a portion of theelongated structure. Accordingly, the wound configuration may extendalong the complete length of the elongated structure, or along a portionthereof, e.g., 20% or more, 30% or more, 40% or more, 50% or more, 60%or more, 70% or more, 80% or more, up to 99%, such as 95%. As such, incertain of these embodiments the insulated conducting members are notpresent in a wound configuration along at least a portion of theelongated structure. In some instances, the wound conducting members maybe wound around a mandrel so as to form a tubular shape. The mandrel mayinclude a removable sheath such that after winding and fixation of theconducting members to the removable sheath, the mandrel may be removed,leaving a freestanding elongated conductor with a lumen, the lumen wallsdefined by the removable sheath.

In some embodiments, the different insulated conducting members mayassume a braided configuration along at least a portion of the elongatedstructure. By “braided configuration” is meant that the conductingmembers are woven or plaited along a length of the elongated structure.In these embodiments, the conducting members assume a braidedconfiguration along at least a portion of the elongated structure.Accordingly, the braided configuration may extend along the completelength of the elongated structure, or along a portion thereof, e.g., 20%or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% ormore, 80% or more, up to 99%, such as 95%. As such, in certain of theseembodiments the insulated conducting members are not present in abraided configuration along at least a portion of the elongatedstructure.

In some embodiments, the different insulated conducting members mayassume a linear configuration along at least a portion of the elongatedstructure. By “linear configuration” is meant that the conductingmembers along the elongated structure are configured in a linear orstraight manner along a long axis of the elongated structure, such asthe central long axis of the elongated structure. In these embodiments,the conducting members assume a linear configuration along at least aportion of the elongated structure. Accordingly, the linearconfiguration may extend along the complete length of the elongatedstructure, or along a portion thereof, e.g., 20% or more, 30% or more,40% or more, 50% or more, 60% or more, 70% or more, 80% or more, up to99%, such as 95%. As such, in certain of these embodiments the insulatedconducting members are not present in a linear configuration along atleast a portion of the elongated structure.

In some embodiments, the insulated conducting members are configured todefine a lumen along at least a portion of the elongated structure. Theterm “lumen” is used in its conventional sense to refer to an innerspace or cavity, e.g., passageway, which extends along at least aportion of the elongated structure. As the conducting members areconfigured to define the lumen, they are configured such that,collectively, they define the walls or boundaries of the lumen. In theseembodiments, the defined lumen may extend along the entire elongatedstructure, or only a portion of the elongated structure, e.g., 20% ormore, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more,80% or more, up to 99%, such as 95%. As such, in certain of theseembodiments the defined lumen is not present along at least a portion ofthe elongated structure. FIG. 3A provides a view of the proximal end andFIG. 3B provides a view of the distal end of an elongated conductor inwhich the conducting members have been wound in manner to produce alumen extending from the proximal to the distal end. As shown in FIG.3A, proximal end 310 of elongated conductor 300 includes an assembly ofwires 320 wound in a helical fashion that defines a central lumen 330.Each of the wires includes an insulation opening 325, where thecollection of insulation openings make up a pattern of axially alignedinsulation openings. The insulation openings 325 are coupled with one ormore components 335. In this instance, the components 335 may be contactpads on a connector, electrodes, etc. As shown in FIG. 3B, distal end340 of elongated conductor 300 includes an assembly of wires 320 presentin a planar configuration. Each of the wires includes an insulationopening 325, where the collection of insulation openings make up apattern of transversely aligned insulation openings. Also shown areregions 350 where the conducting members are not fixed, e.g., to providestrain relief. FIG. 3B also shows mandrel 360 which is used duringfabrication of the structure as a guide about which the conductingmembers are wound to produce the central lumen. In some instances, themandrel 360 may include a removable part, such that after formation andfixation of the elongated conductor 300, the mandrel 360, or a portionthereof may be removed so as to form a lumen there through.

FIG. 3C provides a cross sectional view of the proximal end of theelongated conductor 300 shown in FIG. 3A. The insulated wires 325 areshown in a wound pattern around the mandrel 360. The cross sectionalview passes through a component 335 a adjacent to an insulation window325 a, meant for coupling thereto.

FIG. 3D provides an alternative view of the distal end of the elongatedconductor 300 shown in FIG. 3A. The mandrel 360 is shown passing underthe patterned region. The insulated wires 320 are supported by asubstrate 370. There is a patterned region, a region where the wires arenot coupled together 350, and a region where they are wound about themandrel 360.

In some instances, the lumen may be suitable for passing a fluid alongthe length of the elongated conductor (e.g., for purposes ofheating/cooling, delivery of a coolant, delivery of a drug, amedication, a biological sample, etc.). While the dimensions of thelumen may vary, in some instances the lumen has a diameter ranging from0.025 to 20.0 mm, such as 0.10 to 5.0 mm and including 0.10 to 1.0 mm.

In some instances, the lumen may be occupied by one or more internalcomponents. For example, the lumen may be occupied by one or moreinternal conducting members, which conducting member(s) may occupy theentire lumen or a portion thereof. In one instance of such anembodiment, the elongated conductor includes a central insulatedconductor surrounded by a plurality of peripheral insulated conductors,which peripheral conductors may be wound about the central conductor,braided about the central conductor, or linearly extend along thecentral conductor.

Where desired, the insulated conducting members may be present in asheath. The term “sheath” is employed in its conventional sense to referto an enveloping tubular structure. The sheath, when present, may extendalong the entire elongated structure, or only a portion of the elongatedstructure, e.g., 20% or more, 30% or more, 40% or more, 50% or more, 60%or more, 70% or more, 80% or more, up to 99%, such as 95%. As such, incertain of these embodiments the sheath is not present along at least aportion of the elongated structure. The sheath may be fabricated fromany convenient material, as desired. In some instances, the sheath isfabricated from a conductive material. Conductive materials of interestfor the sheath include, but are not limited to: a thermally conductivematerial, an optically conductive material, an electrically conductivematerial, a conductive polymer, a conducting composite, a metal, aprecious metal, a conducting alloy, silver, copper, platinum, palladium,steel, carbon, stainless steel, an alloy thereof, a composite thereof,and the like. In some instances, the sheath is fabricated from aninsulating material. Insulating materials of interest for the sheathinclude, but are not limited to: a thermally insulating material, anoptically reflective material, an electrically insulating material, apolymer, a thermoset polymer, a thermoplastic polymer, high strengthfibers, a ceramic loaded polymer, a low dielectric polymer, a high fieldstrength polymer, a composite thereof, and the like. In some instances,the sheath is fabricated from a water-impermeable material, by which ismeant that the sheath inhibits passage of water from one side of thesheet to the other. In some instances, the sheath is fabricated from awater retaining material (e.g., a hygroscopic material, a hydrogel,etc.), such that the sheath may provide a lubricating surface for theelongated conductor when placed within an aqueous environment.

Where desired, the insulated conducting members of at least one of theproximal and distal regions are stably associated with a substrate. Forexample, in a region where the conducting members assume a substantiallyplanar (e.g., ribbon) configuration, the conducting members may bestably associated with a substrate, e.g., in the form of a planarsupport. The planar support may be fabricated from any convenientmaterial, e.g., a metal, a ceramic, a cermet, a silicon interposer, aradiopaque material, an adhesive tape, a b-stage able adhesive tape, andthe like. In some instances, the planar support may provide aninterconnect function for one or more of the conducting members. In someinstances, the planar support may provide an insulating property, astructural reinforcement, a precision planarization function, aconducting property (e.g., acting as a heat sink), or the like. Thedimensions of the planar support may vary, where in some instances thesupport has a surface area contacted by conducting members that rangesfrom 100 μm² to 100 mm², such as 1000 μm² to 5 mm² and including 0.5 to1.5 mm².

As indicated above, the insulated conducting members of the elongatedconductors are made up of at least a conducting core present in aninsulating coating. As summarized above, the elongated conductors may beconfigured to conduct different entities, e.g., light, heat, electriccurrent, etc. Where the conductors are configured to convey electriccurrent, i.e., they are electrically conductive, the conductive core maybe fabricated from any convenient electrically conductive material.Electrically conductive materials of interest include, but are notlimited to: metals, e.g., copper, silver, gold, platinum, palladium,titanium, tantalum, etc., alloys, e.g., stainless steel, silver copperalloys, shape memory alloys, e.g., Nitinol™ shape memory alloys, highperformance alloys, beryllium copper alloys, titanium alloys, nickeltitanium alloys, corrosion resistant alloys,cobalt-chromium-nickel-molybdenum-iron alloys, shape memory materials,core shell composite structures, carbons, carbides, composites thereof,alloys thereof, and the like.

The insulating coating surrounding the conductive core may be fabricatedfrom any convenient insulating material. In some instances, thisinsulating coating is fabricated from a thermostable material (i.e. asubstantially thermally stable material with respect to processing andusage conditions expected by the elongated conductor). Thermostablematerials that may be employed include materials having a meltingtemperature that is 20° C. or greater, such as 30° C. or greater,including 40° C. or greater, than the melting temperature of one or morethermoplastic components of the conductor, such as binding components,e.g., as described in greater detail below. Thermostable materials ofinterest include, but are not limited to: a polymer, a ceramic, anoxide, a thermoset polymer, a high melting temperature polymer, achemically resistant polymer, a polyimide, a polyamide, a fluoropolymer,PTFE, a polyurethane, a polyolefin, a polyetheretherketone, a silicone,a cross-linked polymer, composites thereof, glass reinforced versionsthereof, and the like.

Within an elongated conductor, the various conductive members may bestably associated with each other using any convenient approach. In someinstances, the various conductive members are fixed relative to eachother by a thermoplastic material which, during fabrication of theelongated conductor, (e.g., as described in greater detail below) hasbeen molded in manner sufficient so to occupy the spaces between theconductive members and fix the conductive members relative to eachother, e.g., as shown in FIG. 4, described in greater detail below.Thermoplastic materials of interest include, but are not limited to: aplastic, a chemically susceptible polymer, a polyurethane, a polyvinylchloride, a poly butyral, an epoxy, a polyester, a polyamide, Dacron,composites thereof, and the like.

As summarized above, the dimensions of the elongated conductors mayvary. In some instances, the elongated conductors are dimensioned to bepositioned be positioned in mammalian vasculature. The referencevasculature may be from a variety of different mammals. Mammals ofinterest include carnivores (e.g., dogs and cats), rodentia (e.g., mice,guinea pigs, and rats), and primates (e.g., humans, chimpanzees, andmonkeys). In some embodiments, the mammal is a human. The term “human”may include human subjects of both genders and at any stage ofdevelopment (e.g., fetal, neonates, infant, juvenile, adolescent, andadult), where in certain embodiments the human subject is a juvenile,adolescent or adult. While the dimensions of a given elongated conductorof the invention may vary, in some instances the elongated conductor hasa length ranging from 5 to 4,000 mm, such as 50 to 2,000 mm, and anouter diameter ranging from 5 μm to 10 mm, such as 15 μm to 7.5 mm,including 25 μm to 5 mm, where in some instances the outer diameter isvery small, e.g., 5 μm to 500 μm, such as 10 μm to 350 μm, including 15μm to 300 μm.

Where desired, the insulated conductors of at least one of the proximaland distal regions assume a split configuration, e.g., as shown in FIGS.2A-2C.

As indicated above, the elongated conductors may include one or moreshielding components, where such shielding components may vary. Examplesof such shielding components include, but are not limited to: sheaths,such as described above; subgroupings of one or more electricallyconducting members (e.g., wires), which may be arranged around the outerperiphery of the elongated conductor (e.g., in a wound or braidedconfiguration) or may be present in an internal location of theelongated conductor, e.g., one of the internal conducting wires isconnected to another component, e.g., the guidewire, for either afloating shield or a grounded shield); a conductive insulating layer ofone or more conducting members; a binding layer of the elongatedconductor; etc.

As indicated above and detailed further below, the elongated conductormay have a structure that provides for a controlled impedance, at leastalong a portion of the conductor length, e.g., where the controlledimpedance may be viewed as a known fixed impedance/unit length. Thestructure and interaction of components in the elongated conductor canbe chosen to provide for a desired impedance along at least a portionof, if not all of, the length of the elongated conductor, whichimpedance may be tailored to the intended use of the device in which theelongated conductor is to be present. For example, the impedance of theconductor and/or sub-portions thereof may be chosen depending on thetypes of signals that are to be conveyed along the conductor, e.g.,cardiac EPS, neuro, brain, etc., and may be selected to work optimallywith communications units, e.g., RF units, at an end of the conductor.

The elongated conductor may, where desired, be configured to function asa guidewire. In such instances, the elongated conductor is configured asa thin, usually flexible wire that can be inserted into a confined ortortuous space to act as a guide for subsequent insertion of a stifferor bulkier instrument. In such instances, the elongated conductor mayinclude variable mechanical compliance to make the distal tip not only acontact point, but also good as a steering mechanism/function, e.g., asis present in standard guidewires. Where desired, the distal end of theconductor may be shapeable, e.g., as in the bending tips of guidewirescurrently employed for specific anatomic access sites.

In some instances, the elongated conductor may include one or moreradiopaque regions. By radiopaque region is meant that a domain or areaof the elongated conductor that is opaque to one or another form ofradiation, such as X-rays. Radiopaque objects block radiation ratherthan allow it to pass through. Any convenient radiopaque material may bepresent in the radiopaque region(s), where materials of interestinclude, but are not limited to, metals, e.g., tantalum, platinum,palladium, barium sulfate, bismuth sub carbonate, bismuth oxychloride,bismuth trioxide, stainless steel, Nitinol™ shape memory alloys,platinum/iridium, tungsten, filled polymers thereof, a radiopaquepolymer, a composite material, an alloy thereof, a composite thereof,and the like. The radiopaque region may vary in configuration, and maylimited to one or more portions of the elongated conductor, e.g., wherethe elongated conductor includes one or more marker bands made up of aradiopaque material.

The elongated conductors having been generally described, specificexamples of such conductors are reviewed in connection with variousfigures. FIGS. 4A and 4B provide views of complete elongated conductors.FIG. 4A provides a view of an elongated conductor 400 having a proximalregion 410 with an axially aligned pattern of insulation openings and adistal region 420 of transversely aligned insulation openings. Theelongated conductor 400 illustrated in FIG. 4A may be viewed as one thataxially encoded at the proximal end and transversely encoded at thedistal end. FIG. 4B provides a view of another elongated conductoraccording to any embodiment of the invention. The elongated conductor450 includes proximal end 460 and distal end 470, where the body of theelongated conductor is covered by a sheath 475. In this embodiment, thesheath (e.g., an ultrathin hypotube initial structure) can provide acomplete shield, and effectively form a Faraday cage around the entireassembly. Also, the wires themselves are now hermetically sealed withinthe device, and thus can be formed from considerably lower costmaterials than would be the case if they could be exposed to thesurrounding tissues.

FIGS. 5A-5C provide schematics of elongate conductors demonstrating arange of end interconnection options, in accordance with embodiments ofthe invention. FIG. 5A provides a schematic of an elongate conductor 500demonstrating different proximally 505 and distally 510 encoded regionscoupled by an elongate region 515. The individual conducting memberswithin the elongate conductor 500 may be encoded in the regions 505, 510so as to provide a simple handling and robust interconnect feature tocomponents (not explicitly shown), configured to interface with eachregion 505, 510. The elongate region 515 may be configured such that theindividual conducting members therein are fixed relative to each other,so as to enhance mechanical robustness of the assembly duringfabrication, handling, etc.

FIG. 5B provides a schematic illustration of an elongated conductor 520including a proximal 525, and two distal 530, 535 encoded regionscoupled by a plurality of split elongate regions 540, 545 and a unifiedelongate region 550. The proximal 525 and distal 530, 535 encodedregions may be coupled such that a single proximal component (e.g., aconnector, a coupling, etc.) may interface with two components (notexplicitly shown) coupled to the distally encoded regions 530, 535.

FIG. 5C provides a schematic illustration of an elongated conductor 560including multiple proximal 561, 563, and multiple distal 565, 566, 567,569 encoded regions coupled by a plurality of distally split regions577, 579, 581, 583 and proximally split regions 573, 575 and a unifiedelongate region 571. The assembly is suitable for a more complex device,wherein a plurality of connectors (e.g., fluid connectors, electricalconnectors, optical couplings, etc.) may be coupled with a plurality ofeffectors (e.g., fluid delivery elements, integrated circuits, Bragggratings, optical interfaces, etc.). Also shown is a series of splitregions 577, 579 illustrating a daisy chained configuration of encodedregions 567, 569 wherein individual conducting elements within the splitregions 577, 579 may couple to components in the vicinity of bothencoded regions 567, 569.

FIGS. 6A-6D provide illustrations of elongated conductors with highpacking density and specialized conductor arrangements, in accordancewith embodiments of the invention. FIG. 6A provides an illustration ofthe cross section of an elongated conductor including 12 conductingmembers 605 tightly packed into a circular area 607. The packing densityof this arrangement as arranged is approximately 0.74 in the shownconfiguration and will generally be slightly higher after a fixationprocedure as described herein.

FIG. 6B provides an illustration of an elongated conductor including 24conducting members 615 with a first diameter, 2 conducting members 620with a second diameter and two fluid conducting members 625 with a thirddiameter packed into a circular area 627. The packing density of thisarrangement as arranged is approximately 0.77 in the shown configurationand will generally be slightly higher after a fixation procedure asdescribed herein. Such a configuration may be advantageous for providinga combination of sensory signals (i.e., such as via the first conductingmembers 615), power signals (i.e., such as via the second conductingmembers 620), and a fluid (e.g., a coolant, a medicament, etc.) such asvia the fluid conducting members 625 in a highly compact and spaceoptimized structure.

FIG. 6C provides an illustration of an elongated conductor including 14conducting members 630 with a first diameter, 2 twisted pair basedconducting members 635 with a second effective diameter and 2 largerconducting members 640 with a third diameter packed into an ellipticalarea 643. The packing density of this arrangement as arranged isapproximately 0.83 in the shown configuration based on the ellipticalarea 643, and 0.62 based on the equivalent circular area 647 and willgenerally be slightly higher after a fixation procedure as describedherein. Such an arrangement may be advantageous for providing acombination of sensory signals (e.g., such as via the first conductingmembers 630), power signals (e.g., such as via the second conductingmembers 640), and sensitive high speed signals (e.g., via the twistedpair conducting members 635) in a highly compact and space optimizedstructure.

FIG. 6D provides an illustration of an elongated conductor including 6conducting members 650 with a first diameter, 16 reinforcing fibers 655,660, three conducting members 665 with a second effective diameter, and3 larger coaxially oriented conducting members 670 with a third diameterpacked into a circular area 677. The packing density of this arrangementas arranged is approximately 0.917 in the shown configuration basedcircular area 677 and will generally be slightly higher after a fixationprocedure as described herein. Such an arrangement may be advantageousfor providing a combination of sensory signals (e.g., such as via thefirst conducting members 665), power signals (e.g., such as via thesecond conducting members 665), and RF power signals (e.g., viacoaxially conducting members 670) in a highly compact and spaceoptimized structure.

In some instances, one or more of the members may include an actuator(e.g., a pullable fiber used to actuate, bend, tilt, orient, theelongated structure, during use).

Methods of Making

Also provided are methods of making elongated conductors, e.g., asdescribed above. Aspects of the methods include aligning two or moreinsulated conducting members in an elongated configuration having aproximal region and a distal region; and producing a pattern ofinsulation openings among the insulated conducting members at one orboth of the proximal and distal regions. The methods further include,either after or before pattern production, fixing the relative positionof the two or more insulated conducting members along at least a portionof the elongated conductor. Each of these steps of the fabricationmethods is now reviewed in greater detail.

In practicing methods of the invention, two or more insulated conductingmembers may be aligned in an elongated configuration having a proximalregion and a distal region using any convenient protocol. As indicatedabove, the number of wires in a given elongated conductor may vary,where in some instances the number ranges from 2 to 100,000, such as 2to 500, e.g., 5 to 250, including 5 to 100. In some instances, theconducting members are aligned by extending them lengthwise next to eachother. Where desired, tension may be applied at one or both ends of theconducting members in order to provide for consistent linear alignment.Where desired, an aligner, e.g., a guide, microfixture, etc., that holdsthe individual conducting members at predetermined distances from eachother may be employed. The distances between the conducting members mayvary, ranging in some instances from 0.001 to 10 mm, such as 0.1 to 2mm. Where an aligner, such as a microfixture, is employed, theconducting members may be threaded into the aligner in a continuousmanner, which each conducting member being fed to the aligner from aseparate source, e.g., spool. Embodiments of this aligning step may beperformed in pseudo continuous fashion with a dedicated machine, asdesired. The aligned conducting members may assume any desiredthree-dimensional configuration, e.g., planar, tubular, etc., asdesired, where in some instances the aligned conducting members willassume a planar configuration during a first operation and analternative configuration during a following operation. Optionally, thedistal and proximal regions of the aligned conducting members may befixed relative to each other, e.g., may be gripped, pre-bonded, etc., atthis point to form a desired end construction without the need for humanintervention.

As summarized above, methods of fabricating the elongated conductorsfurther include producing a pattern of insulation openings among theinsulated conducting members at one or both of the proximal and distalregions. As such, the methods may include producing a pattern ofinsulation openings at only one of the proximal and distal regions,producing a pattern of insulation openings at both of the proximal anddistal regions, or producing a plurality of patterns along the lengththereof, and/or along split regions thereof. As such, in some instancesthe method includes producing a first pattern of insulation openingsamong the insulated conducting members at the proximal region and asecond pattern of insulation openings among the insulated conductingmembers at the distal region. As described above, the pattern ofinsulation openings may assume a variety of configurations, e.g.,depending on whether the desired pattern in the final elongatedconductor, which may also vary as described above, e.g., it may betransversely aligned, axially aligned, patterned over an area, daisychained along the elongated conductor, etc. The pattern that is producedin aligned conducting members may be one that is chosen in view ofsubsequent manipulation of the conducting members (e.g., as described ingreater detail below) so as to provide for the desired pattern in thefinal product. For example, where the desired pattern in the finalelongated conductor is an axially aligned pattern, and initial patternproduced in the aligned conducting members may be one that gives rise tothe desired axially aligned pattern following winding or wrapping of theconducting members, e.g., as described in greater detail below. In someinstances, the method includes producing first and second patterns ofinsulation openings in the proximal and distal regions that will giverise to an elongated conducting having both a transversely alignedpattern of insulation openings and an axially aligned pattern ofinsulation openings.

The pattern of insulation openings in the proximal and/or distal regionsof the aligned elongated conductors may be produced using any convenientprotocol. Of interest are material removal processes, e.g., laserremoval processes, chemical removal processes, plasma removal processes,etc. In some instances, laser removal protocols are employed, whereexamples of such protocols include those that employ UV, CO₂ and YAGlasers. Protocols that may be employed also include masked removalprotocols, such as masked plasma removal and masked flame removalprotocols. For larger conducting members, more traditional insulationremoval approaches can be used, such as abrasion, etc. For smallerconducting members, non-contact insulation removal may be employed,e.g., to preserve the delicate nature of the conducting members. In highvolume production applications, the insulation of the aligned conductingmembers may be removed with an imaged, large area UV laser beam (e.g.,from an excimer laser, such that each of the windows in the insulationare opened substantially simultaneously). In this way, bulk insulationremoval can occur at a pace of several units per second. The pattern maybe adjusted so as to make the wires suitable for interfacing with aflexible circuit (see below), an interposer, a sensor, a silicon die, aflip chip packaged element, an optical component, a Bragg grating, anoptimized energy transfer structure, for forming a coaxial connector(see below), etc.

As indicated above, a third step employed in production of the elongatedconductors is to fix the relative position of the two or more insulatedconducting members along at least a portion of the elongated conductor.As reviewed above, by fixing is meant stably associating the alignedconducting members, such that the conducting members in the region offixation do not move relative to each other. As also reviewed above, thealigned conducting members may be fixed along their entire length, orthere may be one or more regions along the length of the alignedconductors that is not fixed, e.g., to provide for strain relief. Asalso indicated above, fixation of the aligned conductors may be doneprior to or after production of the pattern(s) of insulation openings.As such, in some instances the aligned conducting members are fixedprior to production of the pattern(s) of insulation openings. In otherinstances, the aligned conducting members are fixed after production ofthe pattern(s) of insulation openings.

The aligned conducting members may be fixed using any convenientprotocol. For example, the aligned conducting members may bemechanically fixed relative to each other, e.g., using any conventionmechanical fixation component, such as but not limited to: a cuff,sheath, etc. Alternatively, a binding material may be employed to fixthe different elongated conducting members relative to each other. Thebinding material may be any of a number of different materials, such asan adhesive, a phase change material, a b-stage able adhesive, a photocrosslink able material, etc. In some instances, the binding material isprovided as an outer layer of the elongated conducting members, whichbinding material is employed during the fabrication process to producethe desired elongated conductors with fixed conducting members.

An example of such an embodiment is where the insulated conductingmembers include an insulation material that is present about theconducting core and a second binding material that is formed about theinsulation material, such that the conducting member has a conductingcore with an inner concentric insulation material and an outerconcentric binding material. The thickness of the insulating materialmay vary, as desired, ranging in some instances from 0.25 to 500 μm,such as 1 to 50 μm and including 5 to 15 μm, where in some instances thethickness is sufficient to electrically isolate one conducting memberfrom another in the finished assembly. The insulation thickness andmaterial composition may be designed so as to maintain the desiredcontrolled impedance between one or more conducting members, e.g.,wires, in the assembly. This insulation may be formulated so as to notsubstantially change state during the bonding process. A variety ofdifferent materials may be employed for the insulation, where materialsof interest include, but are not limited to: a thermally insulatingmaterial, an optically reflective material, an electrically insulatingmaterial, a polymer, a thermoset polymer, a thermoplastic polymer, highstrength fibers, a ceramic loaded polymer, a low dielectric polymer, ahigh field strength polymer, a composite thereof, a plastic, achemically susceptible polymer, a polyurethane, a polyvinyl chloride, apoly butyral, an epoxy, a polyester, a polyamide, Dacron, compositesthereof, a polymer, a ceramic, an oxide, a thermoset polymer, a highmelting temperature polymer, a chemically resistant polymer, apolyimide, a polyamide, a fluoropolymer, PTFE, a polyolefin, apolyetheretherketone, a silicone, a cross-linked polymer, compositesthereof, glass reinforced versions thereof, a radiopaque polymer, apolymer composite including tantalum, platinum, palladium, bariumsulfate, bismuth sub carbonate, bismuth oxychloride, bismuth trioxide,stainless steel, nitinol, platinum/iridium, or tungsten, a compositematerial, an alloy thereof, and the like.

In some instances, the insulating and/or binding layer may include apiezoresistive and/or piezoelectric material such that one or moreelectrical properties of the elongated conductor substantially changeduring flexure, pressure application, contact load along a region of theelongated conductor, etc. In other words, the elongated conductorincludes a piezo component, where the piezo component may be apiezoresistive component or a piezoelectric component. Such componentsmay be used for a variety of different purposes, e.g., to detect tipflexure and force directly by looking at changes in the inter-wireimpedance changes of the overall assembly (which finds use in monitoringmovement feedback and artifact removal, wall pressure application, etc.)When the piezo component is a piezo material incorporated into a layerof the conductor, such as an insulating and/or binding layer, the piezomaterial may extend along the entire length of the conductor or only aportion thereof, as desired. In some instances, the insulating and/orbinding layer may include a region of a carbonyl metal-elastomercomposite (such as a carbonyl nickel-silicone composite), such thatmechanical stress applied to the structure in the vicinity of thecarbonyl metal-elastomer composite would substantially change theelectrical properties thereof.

The outer concentric binding material may vary widely, so long as it canserve to bind the conducting members in a stable configuration in thefinal elongated conductor. In some instances, the binding material isone that can be transitioned between adhesive and non-adhesive states inresponse to an applied stimulus. For example, the outer binding materialmay be one that can be thermally, optically, and/or chemically, alteredas to form a tacky, softened, or adhesive state, which state may beemployed to initial secure the aligned conducting members to each otherin the desired configuration. This state may be a temporary state toprovide a temporal window for processing the wires into the assembly.Following attainment of the desired final arrangement of the conductingmembers in the elongated structure, the state of the binding materialmay be returned to the non-tacky, softened, or adhesive state so as toprovide a stable, durable association of the conducting members on theelongated conductor. A variety of different materials may be employed asthe binding material, where materials of interest include bothconducting materials and non-conducting materials. Conducting materialsof interest include, but are not limited to: inherently conductingpolymers, metal frit filled polymer composites, a silver loadedthermoplastic polymer composite, and the like. Non-conducting materialsinclude, but are not limited to: a plastic, a chemically susceptiblepolymer, a polyurethane, a polyvinyl chloride, a poly butyral, an epoxy,a polyester, a polyamide, Dacron, composites thereof, and the like. Insome instances, the binding material is a thermoplastic material, whichmaterial becomes tacky upon application of heat, e.g., at a temperatureranging from 35 to 500° C., such as 90 to 230° C., and then returns to anon-tacky state upon cooling, e.g., to room temperature. In suchembodiments, the aligned conducting members may be heated to asufficient temperature such that the outer thermoplastic bindingmaterials of the individual conducting members become tacky and mergewith each other. Following this heating step, the resultant structure isallowed cool in a manner such that the merged binding materials of thevarious conducting members have merged into a stable, monolithicstructure which serves to fix the various conducting members relative toeach other.

An example of this procedure is illustrated schematically in FIGS.7A-7C. As shown in FIG. 7A, an initial non-fixed assembly of linearlyaligned wires 701 to 702 are is produced. Each of the wires includes aninner concentric insulating layer, e.g., 701 a, and an outer concentriclayer of a thermoplastic binding material, e.g., 701 b. The wires 701,702 are brought together 705 to form a tightly arranged assembly 710, asshown in FIG. 7B. For fixing the assembly, heat is applied 715 toproduce the a fixed assembly 720 as shown in FIG. 7C which is made up ofwires 701 to 702, where the outer binding material layers of each wirehave merged to produce a binding structure 701 b′ which serves to fixthe assembly of wires together into the assembly. Although not required,the pitch 725 between the wires 701, 702 in the fixed assembly 720 maybe defined primarily by the diameters of the wires 701, 702, and thethickness of the corresponding concentric insulating layers 701 a, whilethe strength with which the assembly is held together is primarilydefined by the corresponding binding materials 701 b. Together, FIGS.7A-7C provide an illustration of a fixing step of a method offabricating at least a portion of an elongate conductor with acontrolled inter-element pitch, in accordance with an embodiment of theinvention.

Prior to the fixation step, e.g., as described above, the conductingmembers may be manipulated to achieve a desired configuration. Forexample, the conducting members may be wound, braided, segmented, splitinto separate sub-groups (e.g., subgroups manipulated separately fromother members of the group, etc.) or otherwise manipulated in order toproduce a desired configuration of conducting members in the finalelongated structure. Any convenient protocol for manipulating theconducting members may be employed. For example, where the conductingmembers assume a wound configuration in the final elongated conductor,the aligned conducting members may be twisted or turned about each otherto provide the final desired configuration. The conducting members maybe wound together, either in initial pairs, groups, etc. or all togetheras a group, so as to form a tightly bound assembly, as desired. Wherethe final elongated conductor includes a lumen, e.g., as describedabove, the conducting members may be wound about a mandrel or analogousstructure, which may then be separated from the conducting membersfollowing fixation to provide the desired elongated conducting memberhaving a lumen. For example, elongated conductors may be configured toprovide for fluid delivery along at least a portion of their length incombination with the electrical/optical interconnections. In theseinstances, a central lumen can be integrated into the elongatedconductor by employing a forming mandrel over which the winding processof the conducting members may be performed. After winding, the finalmandrel may be removed so as to form the lumen (with or without anassociated sheath, as desired). At the ends, the same connectors can beformed, they may just be held during the winding process in order toensure the mandrel does not get in the way during formation of the finalassembly. The hollow center may include a tube, which may be extendedbeyond the ends so as to provide for fluid coupling at either side, inaddition to the associated electrical/optical couplings. Optionally,once wound together, the conducting members may undergo a stress relief,a rewind procedure, etc., as desired.

As reviewed above, the elongated conductors may include a sheath. Toproduce elongated conductors of these embodiments, a fixed assembly ofaligned conducting members, e.g., as described above, may be insertedinto a sheath. As reviewed above, the sheath may be fabricated from aconducting or non-conducting material, as desired. Where the finaldesired elongated conductor includes an outer sheath of narrow diameter,e.g., a sheath having an outer diameter ranging from 0.025 to 20.0 mm,such as 0.10 to 5.0 mm and including 0.10 to 1.0 mm, a sequential sheathinsertion protocol may be employed to position the fixed conductivemember assembly into the final desired sheath. Sequential sheathinsertion protocols are ones that include inserting the alignedinsulating conductors into a first sheath and then inserting a secondsheath into the first sheath between the first sheath and the insulatedconducting members, where the second sheath has an outer diameter thatis shorter than the inner diameter of the first sheath, e.g., by a valueof 0.1 to 500 mm, such as 0.1 to 10 mm, and then separating the firstsheath from the remainder of the assembly (made up of the second sheathand insulating conducting members); where the process may be iterated asdesired to obtain the desired final elongated conductor having a sheathof desired outer diameter. In an example of such fabrication embodiment,a fixed aligned conducting member assembly, e.g., as described above, isthreaded through a relatively larger initial sheath such that it willnot buckle during the insertion process. While the dimensions of thisinitial sheath may vary, in some instances this initial sheath has aninner diameter ranging from 0.05 to 5 mm, such as 0.05 to 0.5 mm, and anouter diameter ranging from 0.075 to 6 mm, such as 0.075 to 0.6 mm.Next, sequentially smaller dimensioned sheaths are threaded through thelarger sheath such that the conductor assembly is constrained frombuckling (i.e., the buckling distance is reduced such that the conductorassembly has nowhere to retreat to during the passage process). In someinstances, the outer diameter of each successively smaller dimensionedsheath is 0.02 to 4.9 mm, such 0.02 to 0.49 mm shorter than the innerdiameter of the preceding sheath employed in the protocol. The outersheath is then removed and the process is repeated as desired. In thisprotocol, the process is continued with smaller and smaller sheathsuntil the final desired sheath is in-place. In this way, elongatedconductors may be fabricated in which the overall inner diameter of thesheath is just barely larger than the overall outer diameter of theconducting member assembly present in the sheath. While the differencein these diameters may vary, in some instances, the difference rangesfrom 0.01 to 0.1 mm, such as 0.01 to 0.05 mm.

In some instances, the methods may include stably associating one orboth of the proximal and distal regions of the aligned conductingmembers with a substrate, such as a planar support, e.g., as describedabove. When associated with a substrate, the end region and thesubstrate may be stably associated with each other prior to or afterfixation of the elongated members, e.g., as described above. Asdescribed above, “stably associating” means fixing the relative positionof the end region and the substrate such that they two associatedcomponents do not move relative to each other under normal conditions ofuse. Stable association may be achieved using any convenient protocol,e.g., via use of adhesives, press fit structures, etc.

In some instances (e.g., in the production of various devices, such asdescribed below), the methods may include conductively, e.g.,electrically, coupling one or more of the conducting members of theelongated structure with one or more other components, e.g., aconnector, an effector, etc., at one or both of the distal and proximalregions of the elongated conductor. The components may be a variety ofdifferent types of components depending on their function in the overalldevice in which the elongated conductor is employed, where examples ofthe types of components that may be present include, but are not limitedto: a wafer, a microcircuit, a flexible substrate, an interposer, aflexible microcircuit, a double sided microcircuit, a flip chipintegrated circuit, a contact pad, an annular contact pad, a ringlet ofa conducting material, an actuator, a pull cable, a pull cable fixationpoint, a sensor, a thermocouple, a pH sensor, a pressure sensor, a flowsensor, a valve, a port, an electromechanical microvalve, a manifold, amicrofluidic element, an electromagnetic microfluidic element, anelectrochemical sensor, a silicon circuit, a CMOS circuit, a CMOScamera, a sensory processing circuit, a transducer, a piezoelectrictransducer, an ultrasound producing element, an ultrasound receivingelement, a diode, a passive electrical element, a bypass capacitor, anoptical element, a lens, a waveguide, a grating, a diffraction grating,a Bragg grating, a chemiluminescent film, a chemiluminescentmicrofluidic structure, etc. The components may be conductively coupledto the one or more conducting members of the elongated conductor usingany of a variety of different approaches. The protocol employed may bechosen based on the particular pattern of insulation openings to whichthe component is to be coupled.

In some instances, the components to be connected include multipleindividual connections which are configured to correspond to the patternof insulation openings of the elongated conductor, thereby provided forrapid, single step operative coupling, where desired. For example, wherethe elongated conductor region, e.g., proximal region, includes anaxially aligned pattern of insulation openings, the following protocolmay be employed to readily couple a connector having multiple individualconnection elements. The proximal pattern of the aligned conductors,e.g., wires, may be staggered axially along the length of the assemblysuch that once wound, each wire is only exposed along a length of theassembly at a known, predetermined location relative to the elongatedconductor as a whole. Then, the distance from the proximal end is aparameter that can be used to automatically encode each wire in theassembly, e.g., such that the pattern of insulation openings at theproximal end is axially encoded. In this way, the conductor may beviewed as one whose proximal region is an axially encoded connectorregion. With respect to the connector in such a protocol, an array ofmultiple individual connection elements may be prefabricated from asheet of parent structure. During fabrication, the array of individualconnection elements may be formed around the proximal end of theassembly, preformed, etc. Examples of such encoding are evidentthroughout this disclosure and are particularly highlighted in FIGS.4A-4B.

In some instances, the connector array may be associated with theelongated conductor at the proximal region, and a single attachmentprocess used to operatively couple each individual connection element ofthe connector to the associated wire in the assembly (as determined byaxial positioning and encoding of the connectors and assembly wires),e.g., by simultaneous press-fitting each connection element about itsinsulation opening. Any additional molding, intermediate materialplacement, etc. may be applied to the structure, as desired. The supportstructure of the connector array, if present, may be removed.Optionally, the entire structure may be swaged down to the final size,as desired.

In those instances where the elongated conductor region, e.g., distalregion, includes a transversely aligned pattern of insulation openings,the following protocol may be employed to readily operatively couple acomponent, such as a flex assembly, to the elongated conductor. Whilealigned, the aligned conducting members, e.g., wires, are stablyassociated with a substrate. Either before or after substrateattachment, a pattern of insulation openings is produced in theconducting members, e.g., using a protocol as described above. Thepattern of insulation openings may be a transverse pattern across theconducting members, where the distance from a flanking conducting memberis a parameter that can be used to automatically encode each conductingmember in the assembly. In this way, the elongated conductor may beviewed as one whose distal region is a transversely encoded connectorregion. The pattern may be one that allows for simplified reflowattachment to a flex substrate, attachment via a z-axis adhesive, apatterned conductive adhesive, etc. Spacing, patterns, etc. can beeasily controlled so as to optimize the subsequent flex assemblyattachment. Where desired a single “flip-chip” like assembly operationmay be employed. Optionally, the pattern may be modified, e.g., bypre-wetting, plating-up, or “bumping” one or more of the openings, asdesired, so as to more readily make connections to a flex assembly.Where desired, the conducting members near the connector may becollectively arranged so as to form a micro-strain relief. This approachfurther helps to maintain the mechanical robustness of the overalldevice after completed.

FIG. 8A provides a schematic of portions of a method of fabricating anelongated conductor, in accordance with an embodiment of the invention.FIG. 8A shows the steps of patterning one or more windows into theconducting members, arranging the conducting members together so as toform a desired pattern between the windows and a desired shape of theassembly, and forming one or more structures from the assembly, such asfixing relative positioning of the conducting members with a method inaccordance with the present disclosure.

FIGS. 9A-9B provide illustrations of steps of a method for fabricatingan elongated conductor 900, in accordance with an embodiment of theinvention. FIG. 9A shows a method for patterning 903 an array of windowsinto the insulation 910 of the conducting members of the elongatedconductor 900 wherein the conducting element 907 of the conductingmember is exposed in the vicinity of each patterned window. The methodillustrates some non-limiting patterns, including single circumferentialstripped insulation 905, half circumferential stripped insulation 915,circle shaped stripped insulation 920, elongated regions of strippedinsulation 925, an array of circular windows 930 on a single conductingmember, and an array of circumferentially stripped insulation 935. Thepatterned windows 905, 915, 920, 925, 930, 935 collectively form apatterned region. After patterning, the conductive members areoptionally arranged 940 into a final configuration 945. In thisnon-limiting example, the final configuration 945 is fixed by attachmentto a supporting substrate 947 (e.g., a component, a simple supportingfilm, an interposer, an integrated circuit, a flexible circuit, etc.).In some instances, the patterns may be arranged such that the conductingmembers may be directly interfaced with a target component, or the like.

FIG. 9B provides an illustration of a method for patterning 953 an arrayof windows 955, 960, 965, 970, 975, 980 into the insulation of theconducting members of the elongated conductor 950 wherein the conductingelements of the conducting member are exposed in the vicinity of eachpatterned window 955, 960, 965, 970, 975, 980. In this non-limitingexample, the patterned windows 955, 960, 965, 970, 975, 980 are arrangedaxially along the length of the conducting members, such that, at eachposition along the length of the elongated conductor 950, particularconducting members are windowed, and other conducting members areinsulated. FIG. 9B also shows bringing the conducting members together985 (i.e. in this non-limiting instance, wrapping them around amandrel), and forming a final shape 990 (i.e. in this non-limitinginstance a helical tubular structure). In some instances, additionalelements may be added to the assembly to alter the properties thereof.Additional wires may be added to form a shield, structural fibers may beintegrated so as to strengthen the final shape 990, etc.

FIGS. 10A and 10B provide illustrations of cross sections of an elongateconductor before and after a fixing step of a method for fabricating anelongated conductor, in accordance with an embodiment of the invention.FIG. 10A shows a cross section of an elongated conductor 1000 with 7conducting members 1001, each with a first insulation layer 1003, and asecond binding layer 1005, the conducting members 1001 having beenbrought together during a previous operation. The assembly is then fixed1010 to form a final assembly 1015 wherein the individual conductingmembers 1001 are structurally bound together through the modified secondbinding layer 1005′.

FIG. 10B shows a cross section of an elongated conductor 1050 including12 conducting members 1051, each with a first insulating layer 1053, anda second binding layer 1055, the conducting members 1051 wrapped arounda mandrel 1057 (i.e. in this case a thin walled tube configured toprovide a lumen along the length of the elongated conductor 1050). Theassembly is then fixed 1060 into a final assembly 1065 wherein theindividual conducting members 1051 are at least somewhat held togetherwith the modified second binding layer 1055′.

In some instances, the binding layer 1005, 1055 may be insulating. Inother instances, the binding layer 1005, 1055 may be substantiallyconducting, so as to provide a shielding function for the conductingmembers 1001, 1051 in the elongated conductor 1000, 1050. In someinstances, additional elements may be added to the assembly including,but not limited to: strengthening fibers, lumens (e.g., tubes),additional layers, additional insulating layers, split regions (i.e.,forming the assembly into multiple pathways), addition of components,connectors, addition of optical fibers, etc.

Methods as described herein may be performed in a substantially, if notcompletely, continuous fashion, e.g., where each segment or split regionis formed, wound, advanced and cut free (e.g., singulated), with theprocess being repeated as desired. The final assemblies may then betransferred to an alternative process, integrated into other devices,e.g., full catheters, guidewires, etc., as desired. In certainembodiments, the assemblies may be automatically built without having tocolor code or individually identify any of the conducting members, e.g.,wires, in the assembly (e.g., where assembly formation and final buildcan be automated without the need for human intervention). In practicingembodiments of the invention, reliable assemblies may be produced byforming axially encoded connector contacts to transversely encodedcontacts at either end of the assembly. In this manner, the endconnections are reduced from wire-by wire (2×n identification andconnection operations), to 2 operations (one placement and connectionoperation per end). The resultant elongated conductors of embodiments ofthe methods are mechanically robust, can be handled as a single unit (noneed to handle the tiny wires individually), do not require color codingor individual conductor member identification, can be configured toreadily include a bulk strain relief, and can be threaded through a verytight fitting super-assembly (e.g. a tube, shield, ring connectorassembly, etc.), e.g., as described above.

Devices and Methods of Use

Elongated conductors of the invention, e.g., as described above, finduse in a variety of different devices. In a general sense, the elongatedconductors may be used to conductively, e.g., electrically, connect, anytwo components, where the components are conductively coupled to theconducting members of the elongated conductor at either end of theconductor. General types of devices in which the elongated conductorsfind use include, but are not limited to: communications devices,electronics devices, e.g., consumer and industrial electronics devices,transportation devices, medical devices, robotic assemblies, microrobotic devices, prosthetics, biosimilar devices, surgical devices,flexible conductor assemblies, automotive harnesses, etc.

With respect to medical devices, the elongated conductors find use inconductively, e.g., electrically, connecting, any two components, suchas a proximal end connector and a distal end effector. Proximal endconnectors may vary widely depending on the particular medical device inwhich the elongated conductor is employed, and are configured to serveas a connection between the elongated conductor (and effector coupled tothe distal end thereof) and any of a variety of different devices, e.g.,control devices, data processing devices, data display devices, powerdevices, communications devices, sensory devices, surgical implements,therapeutic devices, etc. A variety of different effectors may beconductively coupled to the distal end of the elongated conductor.Effectors that may be coupled to the distal end of the elongatedconductors may be sensors and/or actuators. Sensing effectors ofinterest, i.e., sensors, may be configured to sense a variety ofdifferent types of data, such as but not limited to: electricalconductivity data, electrical potential data, pressure data, volumedata, dimension data, temperature data, oxygen or carbon dioxideconcentration data, hematocrit data, pH data, chemical data, blood flowrate data, thermal conductivity data, optical property data,cross-sectional area data, change in structure data, viscosity data,radiation data, monitoring an actuation process, and the like.Alternatively, the effectors may be configured for actuation orintervention, such as providing an electrical current or voltage,setting an electrical potential, heating a substance or area, inducing apressure change, releasing or capturing a material, emitting light,emitting sonic or ultrasound energy, emitting radiation, orienting atip, pushing against a surface, opening/closing a fluid channel,releasing a coil, and/or the like.

In some instances, the effector is electrically coupled to the elongatedconductor via circuitry element, such as an integrated circuit. Whenpresent, integrated circuits may include a number of distinct functionalblocks, i.e., modules, where the functional blocks are all present in asingle integrated circuit on an intraluminal-sized support. By singleintegrated circuit is meant a single circuit structure that includes allof the different functional blocks. As such, the integrated circuit is amonolithic integrated circuit (also known as IC, microcircuit,microchip, silicon chip, computer chip or chip) that is a miniaturizedelectronic circuit (which may include semiconductor devices, as well aspassive components) that has been manufactured in the surface of a thinsubstrate of semiconductor material. The integrated circuits of certainembodiments of the present invention are distinct from hybrid integratedcircuits, which are miniaturized electronic circuits constructed ofindividual semiconductor devices, as well as passive components, bondedto a substrate or circuit board, such as may be supported on aninterposer, an intermediate printed circuit board, an HDI flexiblecircuit, etc.

The support with which the circuit is associated, e.g., by being presenton surface of the support or integrated, at least partially, inside ofthe support, may be any convenient support, and may be rigid or flexibleas desired. Where the support is intraluminal sized, its dimensions aresuch that it can be positioned inside of a physiological lumen, e.g.,inside of a vessel, such as a cardiac vessel, e.g., a vein or artery. Incertain embodiments, the intraluminal sized integrated circuits have asize (e.g., in terms of surface area of largest surface) of betweenabout 0.05 mm² and about 10 mm², such as between about 0.5 mm² and about8 mm², and including about 1.5 mm². The supports of the integratedcircuits can have a variety of different shapes, such as square,rectangle, oval, and hexagon, irregular, etc.

Devices, such as described above, may be produced using any convenientprotocol. In some instances, methods of producing the devices include atleast the following steps: providing an elongated conductor of theinvention, e.g., as described above; and operatively, e.g.,electrically, coupling a connector to the proximal end of the elongatedconductor and an effector to the distal end of the elongated conductor,either directly or through an integrated circuit, e.g., as describedabove.

One type of medical device in which the elongated conductors find use isintraluminal medical devices, i.e., medical devices configured to beintroduced into a lumen of a subject sense and/or modulate variousphysiological parameters, where examples of such devices include, butare not limited to catheter based devices, guidewire based devices, etc.An example of such a device is an interventional tool (e.g., amicrosurgical tool) configured for monitoring electrophysiologicalactivity within the vicinity of a lumen, the microsurgical toolincluding a one or more distinct sensing and/or actuating elements,e.g., in the form of microfingers, having a substantially elongatestructure configured so as to bias a region thereof against a wall ofthe lumen upon deployment within the lumen, and a sensing tipelectrically and mechanically coupled to the microfinger in the vicinityof the region, configured to interface with the wall of the lumen, thesensing tip configured to convey one or more electrophysiologicalsignals associated with the activity. Such devices are further describedin PCT application serial no. PCT/US2014/031962 published asWO2014160832 and titled “Neurological Traffic And Receptor EvaluationAnd Modification: Systems And Methods”, the disclosure of which isherein incorporated by reference. Other such devices in which theelongated conductors find use include, but are not limited to: thosedevices described in: PCT application serial no. PCT/US2013/023157published as WO 2013/112844 and titled “Controlled Sympathectomy andMicro-Ablation Systems and Methods”; PCT application serial no.PCT/US2013/042847 published as WO 2013/181137 and titled “EndoscopicSympathectomy Systems and Methods”; PCT application serial no.PCT/US2013/045605 published as WO 2013/188640 and titled “Devices,Systems, And Methods for Diagnosis and Treatment of Overactive Bladder”;PCT application serial no. PCT/US2013/067726 published as WO 2014/070999and titled: “Systems, Methods, And Devices For Monitoring And TreatmentOf Tissues Within And/Or Through A Lumen Wall”; and PCT applicationserial no. PCT/US2013/073844 published as WO/2014/089553 and titled:“Systems and Methods for Regulating Organ and/or Tumor Growth Rates,Function, and/or Development”; the disclosures of which applications areherein incorporated by reference.

As disclosed in the above applications, use of such devices may includecontacting the effector, e.g., sensor and/or actuator, of such a deviceto a tissue location of a living subject. Contact of the effector withtissue may be achieved via a variety of different protocols depending onthe location of the target tissue, e.g., where the target tissue isinternal, contact may be achieved via an intravascular approach. Thedevices may be employed with a variety of different types of subjects.Generally such subjects are “mammals” or “mammalian,” where these termsare used broadly to describe organisms which are within the classmammalia, including the orders carnivore (e.g., dogs and cats), rodentia(e.g., mice, guinea pigs, and rats), and primates (e.g., humans,chimpanzees, and monkeys). In certain embodiments, the subjects arehumans. The methods may be diagnostic and/or therapeutic methods.

Aspects of the invention further include kits that include deviceshaving an elongated conductor of the invention, e.g., as describedabove. Such kits at least include an elongated conductor, e.g., asdescribed above. The kits may include one or more additional componentsthat may find use with the device that includes the elongated conductor.The device (and other components when present) of the kits may bepresent in a suitable container, such as a sterile container, e.g., asterile pouch.

In addition to the above components, the subject kits may furtherinclude (in certain embodiments) instructions for practicing the subjectmethods. These instructions may be present in the subject kits in avariety of forms, one or more of which may be present in the kit. Oneform in which these instructions may be present is as printedinformation on a suitable medium or substrate, e.g., a piece or piecesof paper on which the information is printed, in the packaging of thekit, in a package insert, etc. Yet another form of these instructions isa computer readable medium, e.g., portable flash drive, diskette,compact disk (CD), Hard Drive etc., on which the information has beenrecorded. Yet another form of these instructions that may be present isa website address which may be used via the internet to access theinformation at a removed site.

The following examples are offered by way of illustration and not be wayof limitation.

EXPERIMENTAL Example 1 Production of Elongated Conductor with 12Conducting Members

An elongated conductor with 12 conducting members is formed. Theconducting members are formed from a copper alloy (with nominal diameterof approximately 25 μm) with a first polyimide insulation layer (withthickness of approximately 3.5 μm) and a second polyvinyl butyralbinding layer (with thickness of approximately 3 μm). The conductingmembers are arranged along a horizontal plane with approximately 0.5 mmspacing between individual conducting members, and the proximal anddistal encoded windows are formed in the polyimide and polyvinyl butyrallayers with an ultraviolet laser ablation source. In this non-limitinginstance, the distal encoded windows are patterned so as to form a 2Darray of windows (for later attachment to a planar component as a singleconnector) with windows substantially oriented to one side of theworking plane, and the proximal encoded windows are patterned so as toform a substantially 1D axial array of windows (for later attachment toconcentric connector elements), the windows being substantially fullycircumferential windows around each wire at a spacing of 1.5 mm betweenwindow centers and a window sizing of 0.75 mm each along the wirelengths. The conducting members are then brought closer together througha fixture. The conducting members at the distal tip are arranged with apitch of 45 μm (total width of 530 μm), and fixed through attachment toa reinforced thin tape element. While the distal end is clamped justahead of the fixed region, in a thermally protected arrangement, theremainder of the elongated conductor is wound about an axis, so as toform a tight cylindrical structure with a diameter of approximately 155μm. The assembly is fixed into a final shape by application of heat froma heat gun, thus forming a final solidly connected assembly. Theassembly is singulated to form a final assembly unit. The assembly unitis threaded through an extra-thin walled hypotube with an OD of 254 μmand a nominal ID of 190 μm. The resulting structure is ready forattachment of components to the ends thereof.

In this non-limiting example, the distal end is attached to a miniatureHDI flexible circuit with pre-wetted contacts patterned so as to alignwith the distal end windows in the elongated conductor. The contacts arelined up, slight pressure is applied to the resulting interface and thepre-wetted contacts are reflowed to from a secure interconnectionbetween the flexible circuit and the elongated conductor. Alternatively,in some instances, the attachment process may have been performed with amicro-patterned conductive adhesive, a z-axis adhesive, or the like.

In this non-limiting example, the proximal end is threaded through aconcentric axial connector formed from a beryllium copper alloy with ODof 260 μm and an ID of 185 μm with pre-wetted inner surfaces on thecontact pads of the connector. The whole connector is thermally reflowedwhen in position to form an interconnection between the elongatedconductor and the connector. Support materials are cut away and thefinal connector is swaged to form a final cylindrical shape.

Such an arrangement may be advantageous for use as a micro guide wire inan interventional application.

Example 2 Production of Elongated Conductor with Distal SplitConfiguration

The same procedure is followed up until the step of attaching the distalregion to the support. Instead the distal region is broken into twogroups of 6 conducting members, and each of the groups is attached to aseparate support so as to form a split arrangement. The total width ofeach split arrangement is 238 μm (40 μm pitch between conductingmembers). An additional 4 mm long length of the split regions is clampedbefore proceeding with the winding step outlined in Example 1. The splitdistal patterns are then attached to each side of an HDI flex circuit,so as to form a robust interconnect with a narrow overall width of 245um. An ultra-thin walled polymer sheath is placed around the distalregion to bridge across the hypotube to form a low profile distal partof the assembly. The distal region is potted with a silicone adhesive toform a secure structure at the distal end of the assembly.

Example 3 Elongated Conductor with Flexible Shield

An elongated conductor with 12 conducting members and a flexible shieldis formed. The conducting members are formed from a copper alloy (withnominal diameter of approximately 25 μm) with a first polyimideinsulation layer (with thickness of approximately 3.5 μm) and a secondpolyvinyl butyral binding layer (with thickness of approximately 3 μm).The conducting members are arranged along a horizontal plane withapproximately 0.5 mm spacing between individual conducting members, andthe proximal and distal encoded windows are formed in the polyimide andpolyvinyl butyral layers with an ultraviolet laser ablation source. Inthis non-limiting instance, the distal encoded windows are patterned soas to form a 2D array of windows (for later attachment to a planarcomponent as a single connector) with windows substantially oriented toone side of the working plane, and the proximal encoded windows arepatterned so as to form a substantially 1D axial array of windows (forlater attachment to concentric connector elements), the windows beingsubstantially fully circumferential windows around each wire at aspacing of 1.5 mm between window centers and a window sizing of 0.75 mmeach along the wire lengths. The conducting members are then broughtcloser together through a fixture. The conducting members at the distaltip are arranged with a pitch of 45 μm (total width of 530 μm), andfixed through attachment to a reinforced thin tape element. While thedistal end is clamped just ahead of the fixed region, in a thermallyprotected arrangement, the remainder of the elongated conductor is woundabout an axis, so as to form a tight cylindrical structure with adiameter of approximately 155 μm. The assembly is fixed into a finalshape by application of heat from a heat gun, thus forming a finalsolidly connected assembly.

The flexible shield is formed from an array of less than 20 conductingmembers formed from a stainless steel wire with a nominal diameter ofapproximately 12.5 um and a polyamide insulation with thickness ofapproximately 7.5 um. In this non-limiting instance, the flexible shieldis formed from 15 conducting members, which are wound about the wireassembly to form a final structure. Prior to winding, laser ablation isused to form windows in the insulation of the flexible shield conductingmembers such that an electrical interconnect may be formed there betweenafter forming of the final structure. Once formed into position, thefinal structure is heated and cooled to form a final compositestructure. The flexible shield is restrained with a thin electricallyconducting band at either end to keep the wire elements in position andto make an electrical interconnect with the conducting members of theflexible shield during use.

The assembly is singulated to form a final assembly unit. The assemblyunit is threaded through an extra-thin walled hypotube with an OD of 254μm and a nominal ID of 190 μm. The resulting structure is ready forattachment of components to the ends thereof.

Example 4 Elongated Conductor with Controlled Impedance

An elongated conductor with 12 conducting members and two differentialpairs each with a controlled impedance is formed. The conducting membersare formed from a copper alloy (with nominal diameter of approximately25 μm) with a first polyimide insulation layer (with thickness ofapproximately 3.5 μm) and a second polyvinyl butyral binding layer (withthickness of approximately 3 μm). The conducting members are arrangedalong a horizontal plane with approximately 0.5 mm spacing betweenindividual conducting members, and the proximal and distal encodedwindows are formed in the polyimide and polyvinyl butyral layers with anultraviolet laser ablation source. In this non-limiting instance, thedistal encoded windows are patterned so as to form a 2D array of windows(for later attachment to a planar component as a single connector) withwindows substantially oriented to one side of the working plane, and theproximal encoded windows are patterned so as to form a substantially 1Daxial array of windows (for later attachment to concentric connectorelements), the windows being substantially fully circumferential windowsaround each wire at a spacing of 1.5 mm between window centers and awindow sizing of 0.75 mm each along the wire lengths.

Two pairs of wires are brought separately together to form separatetransmission line elements. Each pair is wound to form a separate pair,the pairs heated to fixate the associated conductive members so as toform two transmission lines. The conductor spacing between members of apair is substantially determined by the wire diameter and the thicknessof the first insulating layer. In this, non-limiting instance, thespacing between wires in the transmission line elements areapproximately 32 μm apart and the high frequency characteristicimpedance is approximately 75Ω.

The conducting members are then brought closer together through afixture. The conducting members at the distal tip are arranged with apitch of 45 μm (total width of 530 μm), and fixed through attachment toa reinforced thin tape element. While the distal end is clamped justahead of the fixed region, in a thermally protected arrangement, theremainder of the elongated conductor is wound about an axis, so as toform a tight cylindrical structure with a diameter of approximately 155μm. The assembly is fixed into a final shape by application of heat froma heat gun, thus forming a final solidly connected assembly. Thedifferential lines are embedded in the assembly along with the otherconducting members of the elongated conductor.

Example 5 Elongated Conductor with Flex Sensitive Region

An elongated conductor with 6 conducting members and 6 flex sensitiveregions is formed. The conducting members are formed from a copper alloy(with nominal diameter of approximately 25 μm) with a first polyimideinsulation layer (with thickness of approximately 3.5 μm) and a secondpolyvinyl butyral binding layer (with thickness of approximately 3 μm).The conducting members are arranged along a horizontal plane withapproximately 0.05 mm spacing between individual conducting members, andthe proximal and distal encoded windows are formed in the polyimide andpolyvinyl butyral layers with an ultraviolet laser ablation source. Inthis non-limiting instance, the distal encoded windows are patterned soas to form a 2D array of windows (for later attachment to a planarcomponent as a single connector) with windows substantially oriented toone side of the working plane, and the proximal encoded windows arepatterned so as to form a substantially 1D axial array of windows (forlater attachment to concentric connector elements), the windows beingsubstantially fully circumferential windows around each wire at aspacing of 1.5 mm between window centers and a window sizing of 0.75 mmeach along the wire lengths.

The distal 2D array of windows is provided so as to connect one or moresensors to the distal tip of the assembly, the axial array of windows isprovided so as to connect one or more connector contacts tocorresponding conducting members of the assembly.

Along the length of the wires, in the vicinity of the distal end, aseries of insulation windows are formed in between alternating pairs ofthe conducting members. Windows with 0.5 mm length are formed atpositions 1.0, 4.0, 6.0, 8.0, 10.0, and 12.0 mm from the distal end ofthe assembly (between wires 1-2, 2-3, 3-4, 4-5, 5-6, and 6-1). An inkmade up of a mixture of a piezoresistive ink including a carbonyl nickelparticle system and a silicone elastomer is provided with a filler tosilicone ratio of 6:1 in a solvent carrier. A micro-volume of ink isadministered to the wire pairs at each of the windows so as to produce abridge between the conducting members.

While the distal end is clamped just ahead of the fixed region, in athermally protected arrangement, the remainder of the elongatedconductor is wound about an axis, so as to form a tight cylindricalstructure with a diameter of approximately 95 μm. The assembly is fixedinto a final shape by application of heat from a heat gun, thus forminga final solidly connected assembly. The piezoresistive ink is curedduring this thermal forming process.

Impedance between the conductive members of the finally formed elongatedconductor will change as the conductive member is flexed in the vicinityof each of the windows. The impedance change can be tailored such thatthe high frequency impedance between adjacent wires may be measured todetermine tip flexure of the elongated conductor, but low frequencysignals may be communicated along the wires to a distal chip, integratedcircuit, electrodes, or the like.

Embodiments of the invention provide a number of advantages that havebeen heretofore difficult or costly to achieve. With respect to theelongated conductors themselves, advantages include the ability to haveinsulation openings arranges in up to a 360 arrangement about thesurface of the elongated conductor in the region of interest, e.g., theproximal and or distal region. Because of the methods employed to makethe conductors, such can be readily achieved without unwanteddestruction of insulation in adjacent conducting members. Elongatedconductors of extremely small outer dimension are readily producible. Inthe elongated conductors, near ideal circular packing density (very highpacking density) may be obtained, such that for a given wire count andcore conductor size, an assembly of much smaller diameter than has beenheretofore possible may be produced. Similarly, for a given overalldiameter, much larger core conductor diameters can packed into theconductor, which provides for desirable impedance, strength, and otherproperties. Controlled impedance is also achievable, in that theinsulation properties and thicknesses can be precisely controlled, whichupon bringing the various conducting members together in the assembly,provides for precise control of the impedance between adjacent wiresalong the length of the assembly. For a given wire diameter, a muchfiner pitch than heretofore possible may be obtained. Truly concentricaxial encoding is obtainable in the elongated conductors of theinvention.

Notwithstanding the appended clauses, the disclosure is also defined bythe following clauses:

-   1. An elongated conductor comprising:    -   an elongated structure having a proximal region and a distal        region and comprising two or more insulated conducting members        that are in fixed relative position along at least a portion of        the elongated structure and extend from the proximal region to        the distal region; and a pattern of insulation openings among        the insulated conducting members at one or both of the proximal        and distal regions.-   2. The elongated conductor according to Clause 1, wherein the    elongated structure comprises a first pattern of insulation openings    among the insulated conducting members at the proximal region and a    second pattern of insulation openings among the insulated conducting    members at the distal region.-   3. The elongated conductor according to Clauses 1 or 2, wherein the    elongated conductor comprises a transversely aligned pattern of    insulation openings.-   4. The elongated conductor according to Clauses 1 or 2, wherein the    elongated conductor comprises an axially aligned pattern of    insulation openings.-   5. The elongated conductor according to any of Clauses 1 to 4,    wherein the elongated conductor comprises both a transversely    aligned pattern of insulation openings and an axially aligned    pattern of insulation openings.-   6. The elongated conductor according to any of the preceding    clauses, wherein the structure comprises from 2 to 500 insulated    conducting members.-   7. The elongated conductor according to any of the preceding    clauses, wherein at least a portion of the elongated conductor is    cylindrical.-   8. The elongated conductor according to any of the preceding    clauses, wherein the insulated conducting members assume a wound    configuration along at least a portion of the elongated structure.-   9. The elongated conductor according to any of the preceding    clauses, wherein the insulated conducting members assume a braided    configuration along at least a portion of the elongated structure.-   10. The elongated conductor according to any of the preceding    clauses, wherein the elongated conductor controlled impedance.-   11. The elongated conductor according to any of the preceding    clauses, wherein the insulated conducting members are configured to    define a lumen along at least a portion of the elongated structure.-   12. The elongated conductor according to Clause 11, wherein the    lumen has a diameter ranging from 0.025 to 20.0 mm.-   13. The elongated conductor according to any of the preceding    clauses, wherein elongated conductor comprises an insulated    conducting member packing density ranging from 30 to 90%.-   14. The elongated conductor according to any of the preceding    clauses, wherein elongated conductor comprises an insulated    conducting member pitch ranging from 6 to 250 μm.-   15. The elongated conductor according to any of the preceding    clauses, wherein the insulated conducting members are not in fixed    relative position along at least a portion of the elongated    structure.-   16. The elongated conductor according to any of the preceding    clauses, wherein the insulated conducting members are not present in    a wound configuration along at least a portion of the elongated    structure.-   17. The elongated conductor according to any of the preceding    clauses, wherein the two or more insulated conductors comprise    conductors of differing diameter.-   18. The elongated conductor according to any of the preceding    clauses, wherein the elongated conductor comprises a central    insulated conductor surrounded by a plurality of peripheral    insulated conductors.-   19. The elongated conductor according to any of the preceding    clauses, wherein the insulated conducting members are present in a    sheath.-   20. The elongated conductor according to Clause 19, wherein the    sheath comprises a conductive material.-   21. The elongated conductor according to Clause 19, wherein the    sheath comprises an insulating material.-   22. The elongated conductor according to any of Clauses 19 to 21,    wherein the sheath comprises a water impermeable material.-   23. The elongated conductor according to any of the preceding    clauses, wherein the elongated conductor comprises an electrical    shield component.-   24. The elongated conductor according to Clause 23, wherein the    electrical shield component comprises a sheath.-   25. The elongated conductor according to Clause 23, wherein the    electrical shield component comprises one or more wires.-   26. The elongated conductor according to Clause 23, wherein the    electrical shield component comprises a conductive insulating layer    of one or more electrical conductors.-   27. The elongated conductor according to Clause 23, wherein the    electrical shield component comprises a binding layer of the    elongated conductor.-   28. The elongated conductor according to any of the preceding    clauses, wherein the insulated conducting members of at least one of    the proximal and distal regions are stably associated with a    substrate.-   29. The elongated conductor according to any of the preceding    clauses, wherein the insulated conductors comprise a conductive core    present in an insulating coating.-   30. The elongated conductor according to Clause 29, wherein the    conductive core comprises an electrically conductive material.-   31. The elongated conductor according to any of Clauses 29 to 30,    wherein the insulating coating comprises a thermostable material.-   32. The elongated conductor according to Clauses 29 to 31, wherein    conductive members are stably associated with each other by a    thermoplastic material.-   33. The elongated conductor according to any of the preceding    clauses, wherein the elongated conductor is dimensioned to be    positioned in mammalian vasculature.-   34. The elongated conductor according to any of the preceding    clauses, wherein the elongated conductor has a length ranging from 5    to 4,000 mm.-   35. The elongated conductor according to any of the preceding    clauses, wherein the elongated conductor has an outer diameter    ranging from 75 μm to 5 mm.-   36. The elongated conductor according to any of the preceding    clauses, wherein the insulated conductors of at least one of the    proximal and distal regions assume a split configuration.-   37. The elongated conductor according to Clause 36, wherein the    split configuration is configured to provide for operative coupling    to opposing sides of a component.-   38. The elongated conductor according to Clause 36, wherein the    split configuration is configured to provide for operative coupling    to the same side of a component.-   39. The elongated conductor according to any of the preceding    clauses, wherein the elongated conductor is configured to be    employed in a sensing device.-   40. The elongated conductor according to any of the preceding    clauses, wherein the elongated conductor is configured to be    employed in an actuating device.-   41. The elongated conductor according to any of the preceding    clauses, wherein the elongated conductor is configured to be    employed in sensing and actuating device.-   42. The elongated conductor according to any of the preceding    clauses, wherein the elongated conductor comprises a piezo    component.-   43. The elongated conductor according to Clause 42, wherein the    piezo component comprises a piezoresistive component.-   44. The elongated conductor according to Clause 42, wherein the    piezo component comprises a piezoelectric component.-   45. The elongated conductor according to any of the preceding    clauses, wherein the elongated conductor is configured to function    as a guidewire.-   46. The elongated conductor according to any of the preceding    clauses, wherein the elongated conductor comprises a radiopaque    region.-   47. The elongated conductor according to Clause 46, wherein the    radiopaque region comprises a marker band.-   48. A method of making an elongated conductor, the method    comprising:    -   aligning two or more insulated conducting members in an        elongated configuration having a proximal region and a distal        region; and    -   producing a pattern of insulation openings among the insulated        conducting members at one or both of the proximal and distal        regions.-   49. The method according to Clause 48, further comprising fixing the    relative position of the two or more insulated conducting members    along at least a portion of the elongated conductor.-   50. The method according to Clause 49, wherein the relative position    of the two or more insulated conducting members is fixed after the    pattern of insulation openings is produced.-   51. The method according to Clause 49, wherein the relative position    of the two or more insulated conducting members is fixed before the    pattern of insulation openings is produced.-   52. The method according to any of Clauses 48 to 51, wherein the    method comprises producing a first pattern of insulation openings    among the insulated conducting members at the proximal region and a    second pattern of insulation openings among the insulated conducting    members at the distal region.-   53. The method according to any of Clauses 48 to 52, wherein pattern    of insulation openings is transversely aligned.-   54. The method according to any of Clauses 48 to 52, wherein the    pattern of insulation openings is axially aligned.-   55. The method according to any of Clauses 48 to 54, wherein the    method comprises producing both a transversely aligned pattern of    insulation openings and an axially aligned pattern of insulation    openings.-   56. The method according to any of Clause 48 to 56, wherein the    method comprises winding the insulated conducting members.-   57. The method according to Clause 56, wherein the insulated    conducting members are wound about a mandrel.-   58. The method according to Clause 57, wherein the method comprises    separating the mandrel from the wound insulated conducting members    to produce a lumen in the elongated structure.-   59. The method according to any of Clauses 48 to 58, wherein the    method comprises inserting the aligned insulating conductors into a    first sheath.-   60. The method according to Clause 59, wherein the method further    comprises inserting a second sheath into the first sheath between    the first sheath and the insulated conducting members.-   61. The method according to Clause 60, wherein the method comprises    separating the first sheath from the second sheath and insulating    conducting members.-   62. The method according to any of Clauses 59 to 61, wherein at    least one of the sheaths comprises a conductive material.-   63. The method according to any of Clauses 59 to 62, wherein at    least one of the sheaths comprises an insulating material.-   64. The method according to any of Clauses 48 to 63, wherein the    method comprises stably associating at least one of the proximal and    distal regions with a substrate.-   65. The method according to any of Clauses 48 to 64, wherein the    insulated conductors comprise a conductive core present in an inner    insulating coating and an outer coating.-   66. The method according to Clause 65, wherein the conductive core    comprises an electrically conductive material.-   67. The method according to Clauses 65 or 66, wherein the outer    coating comprises a thermoplastic material.-   68. The method according to any of Clauses 65 to 67, wherein the    inner insulating coating comprises a thermally stable material.-   69. The method according to any of Clauses 67 to 68, wherein the    method comprises heating the thermoplastic material in a manner    sufficient to fix the relative position of the insulted conductors.-   70. The method according to any of Clauses 48 to 69, wherein the    elongated conductor is dimensioned to be positioned in mammalian    vasculature.-   71. The method according to any of Clauses 48 to 70, wherein the    elongated conductor has a length ranging from 5 to 4,000 mm.-   72. The method according to any of Clauses 48 to 71, wherein the    elongated conductor has an outer diameter ranging from 75 μm to 5    mm.-   73. The method according to any of Clauses 48 to 72, wherein the    method is a continuous process.-   74. A device comprising:    -   an elongated conductor according to any of Clauses 1 to 47; a        connector positioned at the proximal end of the elongated        conductor; and an effector positioned at the distal end of the        elongated conductor.-   75. The device according to Clause 74, wherein the effector    comprises a sensor.-   76. The device according to Clause 75, wherein the sensor is    electrically coupled to the insulated conductors by an integrated    circuit.-   77. The device according to any of Clauses 75 to 76, wherein the    sensor comprises a plurality of distinct sensing elements.

78. The device according to Clause 74, wherein the effector comprises anactuator.

-   79. A method of making a device, the method comprising:    -   providing an elongated conductor according to any of Clauses 1        to 47; and    -   operatively coupling a connector to the proximal end of the        elongated conductor and an effector to the distal end of the        elongated conductor.-   80. The method according to Clause 79, wherein the effector    comprises a sensor.-   81. The method according to Clause 80, wherein the sensor is    electrically coupled to the insulated conductors by an integrated    circuit.-   82. The method according to any of Clauses 80 to 81, wherein the    sensor comprises a plurality of distinct sensing elements.-   83. The method according to Clause 79, wherein the effector    comprises an actuator.-   84. The method according to any of Clauses 79 to 83, wherein the    method comprises producing the elongated conductor.-   85. The method according to Clause 84, wherein the elongated    conductor is produced by a method according to any of Clauses 1 to    27 (see above, section II).-   86. A method comprising contacting the effector of a device    according to any of Clauses 74 to 78 with a tissue location of a    living subject.-   87. The method according to Clause 86, wherein the tissue location    comprises, a cavity, a vessel or an organ location.-   88. The method according to Clauses 86 to 87, wherein the living    subject is a mammal.-   89. The method according to Clause 88, wherein the mammal is a    human.-   90. The method according to any of Clauses 86 to 89, wherein the    method is a diagnostic method.-   91. The method according to any of Clauses 86 to 90, wherein the    method is a therapeutic method.

Although the foregoing invention has been described in some detail byway of illustration and example for purposes of clarity ofunderstanding, it is readily apparent to those of ordinary skill in theart in light of the teachings of this invention that certain changes andmodifications may be made thereto without departing from the spirit orscope of the appended claims. Accordingly, the preceding merelyillustrates the principles of the invention. It will be appreciated thatthose skilled in the art will be able to devise various arrangementswhich, although not explicitly described or shown herein, embody theprinciples of the invention and are included within its spirit andscope. Furthermore, all examples and conditional language recited hereinare principally intended to aid the reader in understanding theprinciples of the invention and the concepts contributed by theinventors to furthering the art, and are to be construed as beingwithout limitation to such specifically recited examples and conditions.Moreover, all statements herein reciting principles, aspects, andembodiments of the invention as well as specific examples thereof, areintended to encompass both structural and functional equivalentsthereof. Additionally, it is intended that such equivalents include bothcurrently known equivalents and equivalents developed in the future,i.e., any elements developed that perform the same function, regardlessof structure. The scope of the present invention, therefore, is notintended to be limited to the exemplary embodiments shown and describedherein. Rather, the scope and spirit of present invention is embodied bythe appended claims.

What is claimed is:
 1. A method of making an elongated conductor, themethod comprising: aligning two or more insulated conducting members inan elongated configuration having a proximal region and a distal region,wherein the insulated conductors comprise a conductive core present inan inner insulating coating and an outer coating; and producing apattern of insulation openings among the insulated conducting members atone or both of the proximal and distal regions.
 2. The method accordingto claim 1, further comprising fixing the relative position of the twoor more insulated conducting members along at least a portion of theelongated conductor.
 3. The method according to claim 2, wherein therelative position of the two or more insulated conducting members isfixed after the pattern of insulation openings is produced.
 4. Themethod according to claim 2, wherein the relative position of the two ormore insulated conducting members is fixed before the pattern ofinsulation openings is produced.
 5. The method according to claim 1,wherein the method comprises producing a first pattern of insulationopenings among the insulated conducting members at the proximal regionand a second pattern of insulation openings among the insulatedconducting members at the distal region.
 6. The method according toclaim 1, wherein pattern of insulation openings is transversely aligned.7. The method according to claim 1, wherein the pattern of insulationopenings is axially aligned.
 8. The method according to claim 1, whereinthe method comprises producing both a transversely aligned pattern ofinsulation openings and an axially aligned pattern of insulationopenings.
 9. The method according to claim 1, wherein the methodcomprises winding the insulated conducting members.
 10. The methodaccording to claim 9, wherein the insulated conducting members are woundabout a mandrel.
 11. The method according to claim 10, wherein themethod comprises separating the mandrel from the wound insulatedconducting members to produce a lumen in the elongated structure. 12.The method according to claim 1, wherein the method comprises insertingthe aligned insulating conductors into a first sheath.
 13. The methodaccording to claim 12, wherein the method further comprises inserting asecond sheath into the first sheath between the first sheath and theinsulated conducting members.
 14. The method according to claim 13,wherein the method comprises separating the first sheath from the secondsheath and insulating conducting members.
 15. The method according toclaim 12, wherein at least one of the sheaths comprises a conductivematerial.
 16. The method according to claim 12, wherein at least one ofthe sheaths comprises an insulating material.
 17. The method accordingto claim 1, wherein the method comprises stably associating at least oneof the proximal and distal regions with a substrate.
 18. The methodaccording to claim 1, wherein the conductive core comprises anelectrically conductive material.
 19. The method according to claim 1,wherein the outer coating comprises a thermoplastic material.
 20. Themethod according to claim 19, wherein the method comprises heating thethermoplastic material in a manner sufficient to fix the relativeposition of the insulted conductors.
 21. The method according to claim1, wherein the inner insulating coating comprises a thermally stablematerial.
 22. The method according to claim 1, wherein the elongatedconductor is dimensioned to be positioned in mammalian vasculature. 23.The method according to claim 1, wherein the elongated conductor has alength ranging from 5 to 4,000 mm.
 24. The method according to claim 1,wherein the elongated conductor has an outer diameter ranging from 75 μmto 5 mm.
 25. The method according to claim 1, wherein the method is acontinuous process.